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Adverse Event Report

CARDINAL HEALTH KERRISON C-L DEG 4MM 8" UP TRQ   back to search results
Model Number U-0418
Event Date 09/27/2003
Event Type  Injury   Patient Outcome  Other;
Event Description

During lumbar laminectomy at l4-l5 on a pt the front of the instrument broke off. The case was extended 30 minutes to retrieve the broken piece from the pt's medullar canal. Additionally, the physician had to extend the laminectomy with another kerrison and pt sent to x-ray.

 
Manufacturer Narrative

Visual eval of the broken portion suggests that there is no indication of fissure as evidenced through the uniformity of the distribution of color all-over the cross section of the effected part. This indicates that such failure mode was attributed to high hardness of the material where such fracture will likely to occur due to repeated stress over time (the instrument is relatively old where vendor's lot code and vnm/s lot code are absent not to mention that old inscription of sec on the handle is present). Reports showed that the shafts were indeed subjected to over heat treatment resulting to hardness reading of 52 hrc as opposed to 40-48 hrc requirement per din standards.

 
Search Alerts/Recalls

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Brand NameKERRISON C-L DEG 4MM 8" UP TRQ
Type of DeviceKERRISON C-L DEG 4MM
Baseline Brand NameKERRISON C-L 40 DEG 4MM 8" UP TRQ
Baseline Generic NameKERRISON C-L 40 DEG 4MM
Baseline Catalogue NumberU-0418
Baseline Model NumberU-0418
Baseline Device FamilyINSTRUMENT
Baseline Device 510(K) NumberK943635
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed12/07/1994
Manufacturer (Section F)
CARDINAL HEALTH
1430 waukegan rd
mcgaw park IL 60085
Manufacturer (Section D)
CARDINAL HEALTH
1430 waukegan rd
mcgaw park IL 60085
Manufacturer (Section G)
V. MUELLER NEURO-SPINE
360 industrial rd unit h
san carlos CA 94070
Manufacturer Contact
patty sharpe-gregg
1430 waukegan rd
mcgaw park , IL 60085
(847) 578 -4148
Device Event Key486737
MDR Report Key497990
Event Key472201
Report Number1423507-2003-00142
Device Sequence Number1
Product CodeHAE
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/26/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberU-0418
Device Catalogue NumberU-0418
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/31/2003
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? Unknown
Type of Device Usage Reuse

Database last updated on January 30, 2009

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