FDA Adverse Event Malfunction Summary report: N

4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM F/IM NAILS-STER

MDR report key: 4250601 · Received November 14, 2014

Report

Report Number: 1719045-2014-10590
Event Type: Malfunction
Date Received: November 14, 2014
Date of Event: October 22, 2014
Report Date: October 22, 2014
Manufacturer: SYNTHES MONUMENT
Product Code: HSB
PMA / PMN Number: PK103002
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF BLANK LOT# 7388400, P/N 04.005.418.999 REVEALED NCR (B)(4) WAS GENERATED FOR "SPOTS IN BOTTOM OF DRIVE". NCR IS NOT RELEVANT TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

IT WAS REPORTED THAT ON (B)(6) 2104, A MALE PATIENT WAS IMPLANTED WITH A MULTI LOCK HUMERAL NAIL. DURING THE PROCEDURE, A SCREW WAS INSERTED INTO THE NAIL. THE SCREW WAS FULLY INSERTED WHEN THE HEAD OF THE SCREW BROKE OFF. THE BROKEN SCREW HEAD WAS REMOVED EASILY IN APPROXIMATELY FIVE MINUTES. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE SHAFT OF THE SCREW REMAINS IN THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
736152	4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM F/IM NAILS-STER	ROD, FIXATION, INTRAMEDULLARY	HSB	SYNTHES MONUMENT		7510260

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR