FDA Adverse Event Malfunction Summary report: N

APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

MDR report key: 3962249 · Received July 28, 2014

Report

Report Number: 3003875359-2014-10221
Event Type: Malfunction
Date Received: July 28, 2014
Report Date: April 17, 2014
Manufacturer: SYNTHES HAGENDORF
Product Code: JDQ
PMA / PMN Number: PK110789
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE NUT IS LOOSE. THE INVESTIGATION WAS NOT ABLE TO DETERMINE THE EXACT CAUSE THAT LED TO THE EVENT, THIS COMPLAINT CONDITION IS INDICATIVE OF THE NUT LOOSENED DURING VERSATILE USE. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT COULD BE DETECTED. 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 SCREW FOR FIXING THE SPRING ON THE PROXIMAL TIP IS LOOSE. NO PATIENT WAS INVOLVED IN THIS INCIDENT THIS IS REPORT 1 OF 1 FOR (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
439572	APPLICATION INSTRUMENT FOR STERNAL ZIPFIX	CERCLAGE FIXATION	JDQ	SYNTHES HAGENDORF		7958465

Patients

Seq	Age	Sex	Outcome	Treatment
1