MAUDE Adverse Event Report: SYNTHES BETTLACH HANDLE FOR GOUGES & CHISELS QC; MISC ORTHO SURGICAL INSTR

Catalog Number	397.70
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Date of event is unknown.Device is an instrument and is not implanted/explanted.A review of the device history records has been requested and is currently pending completion.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 following sterile processing that the brown nylon portion of the handle of the chisel had a chunk out of it.No patient involvement.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Manufacturing location: (b)(4).Manufacturing date: june 19, 2009.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this 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.
Additional Manufacturer Narrative
A product investigation was performed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed.There is a chunk of handle missing from the proximal end.The missing piece would be approximately 14.0mm long x 13.0mm wide x 1.0mm thick.In addition to the chunk of handle missing, there are several marks on the proximal end which show post-manufacturing damage resembling either hammer marks or from dropping the device on floor.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.Relevant drawing were reviewed during this investigation.No product design issues or discrepancies were observed.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: HANDLE FOR GOUGES & CHISELS QC
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• MDR Report Key: 6433213
• Report Number: 2520274-2017-11060
• Device Sequence Number: 10842064
• Product Code: LXH
• UDI-Device Identifier: 10886982201058
• UDI-Public: (01)10886982201058(10)2498813
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2017

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: 397.70
• Device Lot Number: 2498813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/17/2017; 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1