FDA Adverse Event Malfunction Summary report: N

XIA 3 TITANIUM TORQUE WRENCH SHORT

MDR report key: 3260222 · Received August 1, 2013

Report

Report Number: 0009617544-2013-00292
Event Type: Malfunction
Date Received: August 1, 2013
Date of Event: May 11, 2013
Report Date: July 5, 2013
Manufacturer: STRYKER SPINE-FRANCE
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

Additional Manufacturer Narrative · 1

METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: NO DEVICE WAS RETURNED FOR EVALUATION OR INSPECTION. FUNCTIONAL INSPECTION: NOT POSSIBLE AS THE DEVICE WAS NOT RETURNED. DEVICE HISTORY REVIEW: A NONCONFORMANCE WAS IDENTIFIED AS THE MEASURING GAUGE DID NOT FIT THE HEX TIP OF THE WRENCHES PER FORM QC (B)(4). HOWEVER, THE ITEMS WERE RECHECKED AND WERE ACCEPTED. A FUNCTIONAL TEST AND A CHECK OF APPEARANCE AND SHAPE WERE DONE ON ALL UNITS FROM THE LOT AND MET SPECIFICATIONS CONCLUSION: NO SAMPLE WAS RECEIVED FOR INVESTIGATION, SO THE CUSTOMER REPORTED EVENT OF A TIP BREAKAGE COULD NOT BE CONFIRMED. FURTHERMORE, ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AND THE INVESTIGATION IS INCONCLUSIVE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE IN SURGERY.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE IN SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360777	XIA 3 TITANIUM TORQUE WRENCH SHORT	INSTRUMENT	LXH	STRYKER SPINE-FRANCE		11E035

Patients

Seq	Age	Sex	Outcome	Treatment
1