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

Catalog Number	03.503.174
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is synthes employee.A review of the device history records has been requested.The device has been 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.
Event or Problem Description
It was reported that on (b)(6) 2018, during a routine inspection, a matrixmandible bending template was found to be broken.There was no known patient or hospital involvement.This report is for one (1) matrixmandible bending template.This is report 1 of 1 for complaint (b)(4).
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.Device history records review was completed for part: 03.503.174, lot: h282361.Manufacturing location: (b)(4), release to warehouse date: apr 14, 2017.No non conformance reports were generated during production.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Visual inspection of the returned bending template performed at customer quality confirmed the condition of device breakage, which agrees with the reported complaint condition.Only the portion of the bending template from 7-20 was returned, the portion from 1-6 was not returned.The fracture site shows deformation consistent with reverse bending prior to breaking.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.The thickness of the returned bending template at location of breakage measured 0.98mm (calipers (b)(4)) which is within specification of 1.0mm +/-0.1mm per template design drawing.The thickness of the returned bending template at location of breakage measured 2.77mm (calipers (b)(4)) which is within specification of 2.6mm +/-0.2mm per template design drawing.The design specified the device to be manufactured from aluminum 1100-0 material.A review of the supplier certificate of compliance in the dhr shows that the raw material was confirmed to be correct per the specification with no relevant non-conformance noted.A definitive root cause for the bending template breaking could not be determined based on the provided information.The fracture site shows deformation consistent with reverse bending prior to breaking.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 THICK STRAIGHT PLATES
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8065559
• Report Number: 2939274-2018-54950
• Device Sequence Number: 11321175
• Product Code: HWT
• UDI-Device Identifier: 10887587012377
• UDI-Public: (01)10887587012377
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 03.503.174
• Device Lot Number: H282361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1