FDA Adverse Event Malfunction Summary report: N

CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

MDR report key: 2853350 · Received November 30, 2012

Report

Report Number: 2530088-2012-01044
Event Type: Malfunction
Date Received: November 30, 2012
Date of Event: November 5, 2012
Report Date: November 5, 2012
Manufacturer: SYNTHES BRANDYWINE
Product Code: HXX
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT. THE DHR WAS REVIEWED AND THERE WERE NO ISSUES DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. PRODUCT DEVELOPMENT EVALUATION: THE HEX TIP HAS BROKEN OFF JUST ABOVE THE TRANSITION TO THE SHAFT. THE BREAK IS JAGGED AS IT GOES AROUND THE PART. SEVERAL WEAR MARKS EXIST ON THE SHAFT WHICH IS CONSISTENT WITH FIELD USE. THE RETURNED DEVICE WAS MANUFACTURED IN SEPTEMBER 1997 AND IS OVER 15 YEARS OLD. THIS ISSUE WAS ADDRESSED ON SEVERAL PRIOR COMPLAINTS AND AS PART OF THE CORRECTIVE ACTION; THE MATERIAL WAS CHANGED FROM (B)(4) STAINLESS STEEL AND WAS IMPLEMENTED ON SHAFT, (B)(4), LOT NUMBERS 4487955 AND 4480644. THE SHAFT ON THIS COMPLAINT IS LOT NUMBER A4GF532 AND WAS MANUFACTURED IN (B)(4) 1997, PRIOR TO IMPLEMENTATION OF THE CORRECTIVE ACTION. PLACEHOLDER.

Description of Event or Problem · 1

DURING A HIP PINNING PROCEDURE, THE SURGEON WAS INSERTING 7.3MM CANNULATED SCREWS WITH THE SCREWDRIVER AND THE TIP OF THE SCREWDRIVER BROKE OFF. THE TIP OF THE SCREWDRIVER WAS RETRIEVED AND THE FACILITY DISCARDED THE TIP. THE SURGEON USED A BACK UP SCREWDRIVER TO COMPLETE HIS PROCEDURE SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CANNULATED 4.0MM HEXAGONAL SCREWDRIVER	HEXAGONAL SCREWDRIVER	HXX	SYNTHES BRANDYWINE		A4GJ367

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR			HEXAGONAL SCREWDRIVER, SCREW