MAUDE Adverse Event Report: SYNTHES BETTLACH FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL; REAMER

Catalog Number	351.16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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).

• Brand Name: FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6414505
• Report Number: 9612488-2017-10123
• Device Sequence Number: 650357
• Product Code: HTO
• UDI-Device Identifier: 10886982193735
• UDI-Public: (01)10886982193735(10)9251157
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 351.16
• Device Lot Number: 9251157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 84