MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

Catalog Number	399.051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.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# 399.051, lot# t100628.Manufacturing location: (b)(4), manufacturing date: apr 29, 2014.No non conformance reports were generated during production.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on apr 29, 2014.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 a broken reduction forceps with serrated jaw was reported by sterile processing.The device was broken into two pieces.There was no patient involvement.This report is for one (1) reduction forceps with serrated jaw 240mm ¿speed lock.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
Device was used for treatment, not diagnosis additional narrative:.A product investigation was performed.Part # 399.051, lot number # t100628 (reduction forceps) was returned and reported to have been found broken during sterile processing.This condition is confirmed; the threaded speed lock shaft has broken off approximately sixteen millimeters from the base of the shaft.It is likely that over two years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition, however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, dhr review, and drawing review were performed as part of this investigation.The device was manufactured in 4/2014 and is over two years old.The balance of the returned device is in otherwise fair condition with some markings, discoloration, and other signs of wear.A drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no ncrs germane to the complaint condition were generated during the production of this device.All measurements have been performed by calipers (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6291098
• Report Number: 9680938-2017-10014
• Device Sequence Number: 16546829
• Product Code: HTD
• UDI-Device Identifier: 10886982202253
• UDI-Public: (01)10886982202253(10)T100628
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/10/2017

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: 399.051
• Device Lot Number: T100628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 02/28/2017; 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1