MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE BENDNG TEMPLATE F/2.0MM BROAD CRESCENT PLATES

Model Number	03.503.173
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, the matrixmandible bending templates was found to be broken during reverse logistics audit of returned device at a third party servicer.There was no patient involvement.This report is for (1) matrixmandible bendng template f/2.0mm broad crescent plates.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: the matrixmand bnd tmpl 2.0 br crescnt pl (p/n: 03.503.173, lot #: h326538) was returned and received at us cq.Upon visual inspection, the device was observed to be broken.No other issues were identified.Dimensional inspection: dimensional inspection of the relevant feature of the received device was performed at cq drawing 03_503_173 rev.E/d thickness- specification: 1 +/-0.10 mm, actual: 1 mm result: pass (caliper ca122p).Document/specification review: the following current and manufactured revision of drawings were reviewed: 2.0mm thk bending template 3x3 hole, crescent, wide matrix mandible : 03_503_173 rev.E/d no design issues or discrepancies were identified.Investigation conclusion the complaint condition was confirmed for the returned devices.No definitive root cause could be determined based on the provided information.The unintended external forces might have contributed to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part # 03.503.173, synthes lot # h326538, supplier lot # h326538, release to warehouse date: 09 jun 2017, supplier: (b)(4).No ncr's were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

• Brand Name: MATRIXMANDIBLE BENDNG TEMPLATE F/2.0MM BROAD CRESCENT PLATES
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12803905
• Report Number: 2939274-2021-06651
• Device Sequence Number: 20220743
• Product Code: HWT
• UDI-Device Identifier: 10887587012360
• UDI-Public: 10887587012360
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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 Model Number: 03.503.173
• Device Catalogue Number: 03.503.173
• Device Lot Number: H326538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown