FDA Adverse Event Malfunction Summary report: N

CANNULATED SCREW DRIVER

MDR report key: 3595 · Received December 30, 1992

Report

Report Number: 3595
Event Type: Malfunction
Date Received: December 30, 1992
Date of Event: November 18, 1992
Report Date: November 30, 1992
Manufacturer: SYNTHES (USA)
Product Code: LRZ
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

LARGE AO CANNULATED SCREWS BEING USED IN LEFT HIP. SCREWDRIVER FRAGMENTED WHILE IN USE. ALL FRAGMENTS REMOVED; CONFIRMED BY C-ARM X-RAY. SCREWDRIVER RETURNED TO SYNTHES FOR REPLACEMENTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		CANNULATED SCREW DRIVER	LRZ	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Other