ZIMMER 00-1146-001-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-16 for ZIMMER 00-1146-001-00 manufactured by Zimmer.

Event Text Entries

[2505] While removing magna-fx screws from patient's left hip, the cannulated screwdriver broke off at the end. Surgeon substituted the cannulated screwdriver (jacobs chuck) wand the shank broke off. Associate then delivered screwdriver, which rounded off at the end. Szcrews removed with vice grips after extended operative timedevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number34545-1993-00002
MDR Report Key6147
Date Received1993-07-16
Date of Report1993-06-18
Date of Event1993-06-10
Date Facility Aware1993-06-10
Report Date1993-06-18
Date Reported to FDA1993-06-18
Date Reported to Mfgr1993-06-10
Date Added to Maude1993-08-09
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameZIMMER
Generic NameMAGNA-FX CANNULATED SCREWDRIVER
Product CodeLRZ
Date Received1993-07-16
Catalog Number00-1146-001-00
Lot Number00394100
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key5837
ManufacturerZIMMER


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-07-16

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