MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE CUTTER FOR MIDFACE PLATES; INSTRUMENT,CUTTING,ORTHOPAEDIC

Model Number 03.503.039

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted.Visual inspection: the plate cutter for midface plates (p/n: 03.503.039, lot number: 3178407) was received at us cq.Upon visual inspection, the spring with slot has broken off.Dimensional inspection: no dimensional inspection was 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 as the spring with slot is broken.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: 03.503.039.Lot: 3178407.Manufacturing site: (b)(4).Release to warehouse date: 26.June 2009.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 on an unknown date, the plate cutter for midface plates was found not functioning as a piece of the cutter is not attached so it will not cut anything.The issue was discovered during restocking of the device.There were no patient and surgical involvement.During manufacturer's investigation of the returned device it was identified that the spring with slot has broken off.This product condition was reassessed and determined to be reportable on march 26, 2020.This report is for one (1) plate cutter for midface plates.This is report 1 of 1 for complaint (b)(4).

• Brand Name: PLATE CUTTER FOR MIDFACE PLATES
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9978405
• MDR Text Key: 188660065
• Report Number: 2939274-2020-01931
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10887587011653
• UDI-Public: (01)10887587011653
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.503.039
• Device Catalogue Number: 03.503.039
• Device Lot Number: 3178407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2009
• 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