MAUDE Adverse Event Report: SYNTHES TUTTLINGEN MATRIXMANDIBLE COMBINATION BENDER; PLIERS,SURGICAL

Catalog Number	03.503.056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: manufacturing date: 15-may-2009.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 14-may-2009.The screws were secured in three places also on the 14-may-2009.No ncrs were generated during production.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 while refilling and assembling a matrix mandible set, it was noticed the spot welded screw in the matrix mandible combination bender had broken and the screw was backing out.No patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product investigation was performed.It was reported that while refilling and assembling a matrix mandible set, it was noticed the spot welded screw in the matrixmandible combination bender had broken and the screw was backing out.No patient involvement.This complaint is confirmed.The m6 screw component (part# 03_503_056_3) has sheared in half.The proximal portion still remains captured in the handle but the distal end (which was staked to the handle in 3 places) has sheared off mid-thread and was not returned to cq.The diameter of the screw at the location of breakage could not be measured during this investigation as it is not accessible (recessed in the device).This was most likely due to application of excessive force, aggressive or mishandling.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MATRIXMANDIBLE COMBINATION BENDER
• Common Device Name: PLIERS,SURGICAL
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6408369
• Report Number: 9680938-2017-10043
• Device Sequence Number: 10772039
• Product Code: HTC
• UDI-Device Identifier: 10887587011776
• UDI-Public: (01)10887587011776(10)T936274
• 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
• Report Date (Section B): 02/22/2017

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: 03.503.056
• Device Lot Number: T936274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1