FDA Adverse Event Malfunction Summary report: N

SCR-DRIVER-HEX Ø3.5 W/T-HANDLE F/PEDIC S

MDR report key: 3072891 · Received April 23, 2013

Report

Report Number: 8030965-2013-01878
Event Type: Malfunction
Date Received: April 23, 2013
Report Date: March 26, 2013
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

THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PERFORMED INVESTIGATION SHOWED A BREAKAGE OF THE CENTERING TIP FROM THE HEX SCREWDRIVER. THE HEXAGON SHOWS WEAR MARKS. THE EXACT CAUSE OF THE OVERLOAD CAN NOT BE DETERMINED. THE SURFACE OF THE BREAK IS HOMOGENEOUS, WHICH IS LEADING TO FLAWLESS MATERIAL QUALITY. THE INSPECTION OF THE MANUFACTURING AND MATERIAL DOCUMENTS SHOWS NO DEVIATION ACCORDING OUR SPECIFICATIONS. A NEW SOLUTION ACCORDING TO THIS HEXAGONAL SCREWDRIVER IS OUR NEWLY DEVELOPED HOLDING SLEEVE PART 314.069. NO PRODUCT FAULT COULD BE DETECTED.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SMALL PIN BROKE OFF THE TIP OF A SCREWDRIVER. BECAUSE OF THIS, THE DRIVER CAN NO LONGER PROPERLY ABSORB THE CLICK X SCREW. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
173824	SCR-DRIVER-HEX Ø3.5 W/T-HANDLE F/PEDIC S		HXX	SYNTHES GMBH		8096679

Patients

Seq	Age	Sex	Outcome	Treatment
1