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

Model Number 03.503.057

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 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
• Type of Device: 03.503.057
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9988199
• MDR Text Key: 188579548
• Report Number: 2939274-2020-02002
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10887587011783
• UDI-Public: (01)10887587011783
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1