MAUDE Adverse Event Report: SYNTHES BETTLACH FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING; REAMER

Catalog Number	351.15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part# 351.15, lot # 2615099: manufacturing location: (b)(4), manufacturing date: 22.Jun.2010: no non conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 a flexible shaft handle with quick coupling was found broken in central sterile processing.There was no patient involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.The returned t-handle with quick coupling was received at cq disassembled in six (6) pieces.No "broken" components were found, but the device has been disassembled/fell apart.During manufacture, the set screw in the knurled collar component is recessed below the surface of the collar and secured with adhesive per product drawing specification.It is noticed that on the returned collar, the set screw has been back out/unthreaded to the point where it now sits proud on the collar surface by approximately 0.5 mm (calipers ca592) and therefore no longer secures the assembly together as evidenced by the device being returned in six (6) components.The complaint condition was most likely due to disassembly at sterile processing for this 6+ year old reusable instrument that is not intended to be disassembled.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already disassembled in six (6) pieces.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.

• Brand Name: FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6378103
• Report Number: 9612488-2017-10088
• Device Sequence Number: 1251824
• Product Code: HTO
• UDI-Device Identifier: 10886982193728
• UDI-Public: (01)10886982193728(10)2615099
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 02/07/2017

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: Health Professional
• Device Catalogue Number: 351.15
• Device Lot Number: 2615099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1