FDA Adverse Event Malfunction Summary report: N

END CAP T2 TIBIA +5 MM

MDR report key: 3813065 · Received May 15, 2014

Report

Report Number: 0009610622-2014-00206
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 21, 2014
Report Date: April 21, 2014
Manufacturer: STRYKER TRAUMA KIEL
Product Code: HSB
PMA / PMN Number: K003018
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE REPORTED EVENT WAS CONFIRMED. THE END CAP WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. APPEARANCE OF FLATTENED / STRIPPED OFF THREAD FLANKS AND MATERIAL DISPLACEMENT AS WELL AS CLEAR TRACES OF CROSS-THREADING INDICATE THAT THE END CAP HAS BEEN INSERTED UNDER MISALIGNMENT BY CONSIDERABLE FORCE. MOST LIKELY THE THREAD OF THE NAIL IS ALSO DAMAGED (SAME MATERIAL AS THE END CAP: BUT THIS COULD NOT BE PROOFED AS THE NAIL WAS STILL IMPLANTED AND THEREFORE NOT AVAILABLE. BASED ON THE ABOVE FACTS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER LINKED TO IMPROPER HANDLING BY THE USER. NO NON-CONFORMITY WAS IDENTIFIED.

Additional Manufacturer Narrative · 1

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE END CAP COULD NOT BE IMPLANTED BECAUSE THE THREADS WERE NOT WORKING.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE END CAP COULD NOT BE IMPLANTED BECAUSE THE THREADS WERE NOT WORKING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290435	END CAP T2 TIBIA +5 MM	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES	HSB	STRYKER TRAUMA KIEL		K819087

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other