FDA Adverse Event Malfunction Summary report: N

HELICAL BLADE COUPLING SCREW

MDR report key: 2961444 · Received February 11, 2013

Report

Report Number: 1719045-2013-10064
Event Type: Malfunction
Date Received: February 11, 2013
Date of Event: January 17, 2011
Report Date: January 17, 2011
Manufacturer: SYNTHES (USA) MONUMENT
Product Code: LXH
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION SHOWED THAT THE COUPLING SCREW WAS RETURNED WITH THE KNOB BROKEN OFF. THE BREAK WAS AT THE SHAFT AND NOT THE WELDED AREA. THERE WERE AXIAL SCRATCHES AND MINOR DENTS IN THE THREADS WHICH INDICATED USE. SPECIFICATION INVESTIGATION DEMONSTRATED THAT THE DIMENSIONS MEASURED MET SPECIFICATIONS. THE COMPLAINT COULD NOT BE CONFIRMED FROM A MANUFACTURING STANDPOINT. SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROCEDURE OF HIP NAILING, THE SURGEON WAS INSERTING THE HELICAL BLADE INTO THE FEMORAL HEAD. WHILE MALATING, THE BACK OF THE INSERTER BROKE OFF. PROCEDURE CONTINUED USING THE SAME DEVICE AND WAS COMPLETED SUCCESSFULLY. ALL PIECES WERE REMOVED FROM THE PATIENT WITH NO HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
549940	HELICAL BLADE COUPLING SCREW		LXH	SYNTHES (USA) MONUMENT		4546590

Patients

Seq	Age	Sex	Outcome	Treatment
1