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Adverse Event Report

DEPUY ACROMED, INC. ACE SPRING PIN   back to search results
Catalog Number 1365
Event Type  Other   Patient Outcome  Other;
Event Description

It was reported to depuy acromed that an ace spring pin was not functioning properly. The product has been returned and is currently being evaluated.

 
Manufacturer Narrative

It was reported to depuy acromed that an ace spring pin was not functioning properly. The product has been returned and is currently being evaluated.

 
Manufacturer Narrative

It was reported to depuy acromed from a distributor in japan that the device had an indicator that did not function properly. The indicator mechanism should become flush with the top surface of the pin after tightening. Evaluation of the returned parts revealed that the retaining clip was not completely seared into the slip slot. The device appeared to be properly assembled, but a functional test showed that there was a slight angle to the clip (due to not being completely seared in the slot). This condition caused inerference for the indicator, allowing it to only partially engange through the hole. These devices are not only distributed in japan. All remaining parts in stock were quarantined and re-inspected. No other discrepant parts were found. A fixture has been added to the pin assembly operation that will properly place the spring clip in the spring clip slot. A functional test will be added to the inspection plan to inspect that the spring clip is properly placed.

 
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Brand NameACE
Type of DeviceSPRING PIN
Baseline Brand NameACE HALO SYSTEMS
Baseline Generic NameHALO, TONGS, PINS
Baseline Catalogue Number1365
Baseline Device FamilyACE HALO SYSTEMS
Baseline Device 510(K) NumberK954069
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed10/24/1995
Manufacturer (Section F)
DEPUY ACROMED, INC.
325 paramount dr.
raynham MA 02767
Manufacturer (Section D)
DEPUY ACROMED, INC.
325 paramount dr.
raynham MA 02767
Manufacturer Contact
325 paramount dr
raynham , MA 02767
(508) 880 -8100
Device Event Key303418
MDR Report Key313727
Event Key294917
Report Number1526439-2001-00001
Device Sequence Number1
Product CodeHAX
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/23/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number1365
Device LOT Number0698W
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/22/2000
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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