MAUDE Adverse Event Report: SYNTHES HAGENDORF MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213

Catalog Number	03.503.047
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.Device is an instrument and is not implanted/explanted.A device history record review was performed for part # 03.503.047, lot # 1924837: manufacturing location: (b)(4), manufacturing date: 15-jul-2008: 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 the product that would contribute to this complaint condition.Subject device has been received and is currently in the evaluation process.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 is reported the tip of a matrix mandible threaded trocar drill guide was found to be broken off.Issue was discovered while inspecting the tray in sterile processing.No issues were reported with the device prior to discovery.No patient or surgical involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product investigation was performed.It is reported the tip of a matrixmandible threaded trocar drill guide was found to be broken off.Issue was discovered while inspecting the tray in sterile processing.The returned threaded drill guide is broken at the distal tip.The device has minor surface wear which does not impact functionality.A visual inspection, drawing review and dhr review were performed as part of this investigation.The complaint is confirmed.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The root cause is likely related to application of excessive off axis force and continued wear over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6171351
• Report Number: 3003875359-2016-10648
• Device Sequence Number: 1110696
• Product Code: FZX
• UDI-Device Identifier: 10887587011738
• UDI-Public: (01)10887587011738(10)1924837
• 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): 11/22/2016

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: 03.503.047
• Device Lot Number: 1924837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1