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Adverse Event Report

AESCULAP AG & CO.KG ABC SCREWDRIVER   back to search results
Catalog Number FJ838R
Event Date 07/18/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

In 2002, during surgery both screwdrivers broke, surgeon left the broken tips in the head of the screw to act as the locking device. During a postoperative x-ray, the surgeon noted both broken pieces had come out of the head of the screws and are now lodged in the patient's soft tissue. 8/02, two x-ray's were taken, one ap and one lateral. Two tips were able to be seen along with a piece of metal. Opened patient for removal. Found the two tips and the piece of metal which appeared to be a piece of shaving from one of the tips or screwdriver. Surgeon locked the screws. Surgery took approximately 1 1/2 hours. Two post-op x-rays were taken. One ap and the other a lateral.

 
Manufacturer Narrative

Two screwdrivers were returned for investigation. The broken tips were not included in the return. The product has been sent to the manufacturer (germany) for a device evaluation. Aesculap will submit a supplemental report, upon receipt of the device evaluation. Note: only the screwdrivers have been forwarded to the manufacturer for evaluation. The broken tips will not be released by the user/facility and are being retained by the hospital's risk management department.

 
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Brand NameABC SCREWDRIVER
Type of DeviceSCREWDRIVER
Baseline Brand NameABC SCREWDRIVER
Baseline Generic NameANTERIOR CERVICAL SPINE PLATES & SCREWS
Baseline Catalogue NumberFJ838R
Baseline Device FamilyABC CERVICAL PLATING SYSTEM
Baseline Device 510(K) NumberK974706
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed12/15/1997
Manufacturer (Section F)
AESCULAP AG & CO.KG
p.o. box 40
tuttlingen
GERMANY 78501
Manufacturer (Section D)
AESCULAP AG & CO.KG
p.o. box 40
tuttlingen
GERMANY 78501
Manufacturer Contact
kathy racosky
3773 corporate parkway
center valley , PA 18034
(800) 258 -1946
Device Event Key398476
MDR Report Key409463
Event Key387091
Report Number2916714-2002-00015
Device Sequence Number1
Product CodeKWQ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 08/06/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2002
Is This An Adverse Event Report? No
Device Operator Health Professional
Device Catalogue NumberFJ838R
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2002
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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