FDA Adverse Event Malfunction Summary report: N

LARGE QUICK COUPLING

MDR report key: 3003503 · Received February 28, 2013

Report

Report Number: 8030965-2013-10447
Event Type: Malfunction
Date Received: February 28, 2013
Date of Event: June 11, 2011
Report Date: June 13, 2011
Manufacturer: SYNTHES GMBH
Product Code: FZX
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, 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 ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES. THE MFG VISUAL EVAL NOTED DAMAGE ON THE SCREWDRIVER SHAFT. THE INSPECTION HAS SHOWN THAT THE SHAFT OF THE QUICK COUPLING IS COMPLETELY WORN OUT. THE FACE ON THE SHAFT HAS CLEARLY VISIBLE WEAR MARKS.

Description of Event or Problem · 1

ACCORDING TO THE RPTR, ON AN OSTEOTOMY PROXIMAL FEMUR PROCEDURE: THE START/HEX DRIVE SCREWDRIVER SHAFT (03.010.151) BECAME STUCK IN THE CHUCK ATTACHMENT. THE SURGEON WAS ABLE TO FREE THE SCREWDRIVER SHAFT WITH PLIERS AND COMPLETED THE PROCEDURE. ON THE SAME PROCEDURE CASE, THE SURGEON COMPLAINED THAT THE CHUCK ADAPTER QUICK COUPLING (338.49) WILL NOT HOLD THE DRILL BIT. THE BIT SLIDES AROUND, MAKING THE BIT EFFECTIVE. THE SURGEON USED ANOTHER CHUCK ADAPTER AND ATTACHED TO A JACOBS CHUCK TO COMPLETE THE PROCEDURE W/O FURTHER INCIDENT. NOTHING BROKE, NOTHING TO RETRIEVE. THIS COMPLAINT IS ON THE QUICK COUPLING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
87027	LARGE QUICK COUPLING		FZX	SYNTHES GMBH		1124272

Patients

Seq	Age	Sex	Outcome	Treatment
1