FDA Adverse Event Malfunction Summary report: N

FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL

MDR report key: 6414505 · Received March 17, 2017

Report

Report Number: 9612488-2017-10123
Event Type: Malfunction
Date Received: March 17, 2017
Report Date: February 24, 2017
Manufacturer: SYNTHES BETTLACH
Product Code: HTO
UDI-DI: 10886982193735
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 351.16, LOT# 9251157. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: DEC 11, 2014. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DURING A TIBIAL NAILING PROCEDURE ON (B)(6) 2017, THE SURGEON WAS GOING TO USE A FLEXIBLE SHAFT CONNECTOR WITH HAND DRILL BUT IT WAS FOUND BROKEN. IT WAS UNKNOWN WHEN THE DEVICE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT HARM. THIS CASE IS LINKED TO (B)(4). THIS REPORT IS FOR ONE (1) FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
196876	FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL	REAMER	HTO	SYNTHES BETTLACH		9251157	10886982193735

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR