FDA Adverse Event Malfunction Summary report: N

PFNA-II Ø10 SM 130° L200 TAN

MDR report key: 3912116 · Received July 3, 2014

Report

Report Number: 9612488-2014-10262
Event Type: Malfunction
Date Received: July 3, 2014
Report Date: June 5, 2014
Manufacturer: SYNTHES BETTLACH
Product Code: HSB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PRODUCTS IN QUESTION WERE USED FOR A TROCHANTERIC FRACTURE OPERATION ON (B)(6) 2014. AFTER THE OPERATION, BY CHECKING THE X-RAY, THE SURGEON FOUND OUT THAT THE BLADE WAS OUT OF BOUND AND WAS NOT FIXED PROPERLY. THE NAIL WAS ALSO NOT FIXED IN THE FORMER AREA. UPON INSERTION OF THE GUIDE WIRE FOR THE BLADE, THE SURGEON REPOSITIONED WITH THE HANDLE IN HIS HAND, WHICH COULD HAVE CAUSED TENSION TO THE DEVICE, AND LED TO THIS ERROR. ON (B)(6) 2014, THE BLADE IN QUESTION WAS REMOVED AND REPLACED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
390106	PFNA-II Ø10 SM 130° L200 TAN	ROD, FIXATION, INTRAMEDULLARY	HSB	SYNTHES BETTLACH		8799645

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR