FDA Adverse Event Malfunction Summary report: N

130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAI

MDR report key: 2945301 · Received February 1, 2013

Report

Report Number: 2530088-2013-10018
Event Type: Malfunction
Date Received: February 1, 2013
Date of Event: February 28, 2011
Report Date: February 28, 2011
Manufacturer: SYNTHES (USA) BRANDYWINE
Product Code: FZX
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. VISUAL EVALUATION REVEALED THERE WAS NO VISIBLE DAMAGE, EXCEPT FOR HEAVY SIGNS OF USE. A RE-INSPECTION REVEALED ALL PARTS ARE IN PLACE AND THE DEVICE DOES TARGET AS REQUIRED, NO DEVIATION TO THE SPECIFICATION WAS FOUND. BASED ON THE CONDITION OF THE REPORTED EVENT AND THE CONDITION OF THE RETURNED DEVICE THE CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, AS THE RETURNED DEVICE DOES NOT MATCH THE REPORTED EVENT.

Description of Event or Problem · 1

DURING THE SURGERY, THE 130 DEGREE AIMING ARM FELL APART. THE METAL CAP OF THE KNOB BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED FROM THE PT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THIS EVENT DID NOT PROLONG THE SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
43761	130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAI		FZX	SYNTHES (USA) BRANDYWINE		4377505

Patients

Seq	Age	Sex	Outcome	Treatment
1