FDA Adverse Event Malfunction Summary report: N

SCRDRIVERSHAFT T25 LONG STRAIGHT TIP W/H

MDR report key: 3083399 · Received April 29, 2013

Report

Report Number: 8030965-2013-11194
Event Type: Malfunction
Date Received: April 29, 2013
Date of Event: March 29, 2012
Report Date: April 2, 2012
Manufacturer: SYNTHES GMBH
Product Code: HXX
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: 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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND THE TIP OF THE SCREWDRIVER WAS COMPLETELY BROKEN OFF. ACCORDING TO THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE SCREWDRIVER WAS NOT USED WITH THE T-HANDLE (TORQUE LIMITER) WHICH CAUSED THE BREAKAGE. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

Additional Manufacturer Narrative · 1

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 MATRIX REVISION, THE SCREWDRIVER BROKE DURING LOOSENING OF THE SCREWS. ALL BROKEN PARTS WERE RETRIEVED. THIS IS REPORT 7 OF 7 FOR FILE (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
185061	SCRDRIVERSHAFT T25 LONG STRAIGHT TIP W/H		HXX	SYNTHES GMBH		7705789

Patients

Seq	Age	Sex	Outcome	Treatment
1