MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE SHORT CUT PLATE CUTTER; INSTRUMENT,CUTTING,ORTHOPAEDIC

Model Number	03.503.057
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 sales consultant.A device history record (dhr) review was conducted: part: 03.503.057, lot: 1835097.Manufacturing site: (b)(4).Release to warehouse date: 15 may 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.A product investigation was conducted.Visual inspection: the matrixmandible short cut plate cutter (p/n 03.503.057, lot 1835097) was received with the cutter head broken into two pieces.The transverse fracture was between the attachment holes for the two holding wires on the cutter head.No other issues were identified with the returned components of the device.The device failure/defect of broken cutter was identified during the investigation and is related to the reported complaint condition.Dimensional inspection: cutter thickness, adjacent to fracture was measured and found to be confirming per relevant drawing.Document/specification review: the relevant drawings, reflecting the manufactured and current revisions, were reviewed.Dimensional changes to the cutting feature were made to improve the strength of the cutter head with an updated drawing released for the cutter head in april 2010.Since the device was manufactured prior to the design change the device design likely contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the matrixmandible short cut plate cutter (p/n 03.503.057, lot 1835097) as the cutter head was broken into two pieces.Based on the available information it is not possible to determine a definitive root cause, but since the device was manufactured prior to the design change, the device design likely contributed to the complaint condition.The current design was determined to be suitable for the intended use when employed and maintained as recommended.Therefore, from a design perspective this complaint is valid but is already being addressed under corrective and preventative action.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 on (b)(6) 2019, during inspection of field equipment matrix mandible set, the matrixmandible short cut plate cutter was noticed to be broken.There was no patient involvement.This report is for one (1) matrixmandible short cut plate cutter this is report 1 of 1 for complaint (b)(4).

• Brand Name: MATRIXMANDIBLE SHORT CUT PLATE CUTTER
• Common Device Name: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8799985
• Report Number: 2939274-2019-59244
• Device Sequence Number: 11533549
• Product Code: HTZ
• UDI-Device Identifier: 10887587011783
• UDI-Public: (01)10887587011783
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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: 03.503.057
• Device Catalogue Number: 03.503.057
• Device Lot Number: 1835097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1