MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE SHORT CUT PLATE CUTTER; 03.503.057

Model Number	03.503.057
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter company employee.A product investigation was conducted.Visual inspection: the matrixmandible short cut plate cutter (p/n: 03.503.057, lot number: l259491) was received at us cq.Upon visual inspection, the cutting head jaws are deformed.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed the cutting head jaws are deformed.No definitive root cause could be determined based on the provided information.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.A device history record (dhr) review was conducted: part: 03.503.057.Lot: l259491.Manufacturing site: (b)(4).Release to warehouse date: 10.Feb.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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 an unknown date, during routine incoming inspection of loaner set it was observed that the matrixmandile short cut plate cutter was damaged.There was no patient involvement.During manufacturer's investigation of the returned device it was identified that the cutting head jaws are deformed.This product condition was reassessed and determined to be reportable on april 3, 2020.This report is for one (1) matrixmandible short cut plate cutter.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE SHORT CUT PLATE CUTTER
• Common Device Name: 03.503.057
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9988199
• Report Number: 2939274-2020-02002
• Device Sequence Number: 14377689
• Product Code: HTZ
• UDI-Device Identifier: 10887587011783
• UDI-Public: (01)10887587011783
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: L259491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1