MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MESH PLATE CUTTERS; INSTRUMENT,CUTTING,ORTHOPAEDIC

Model Number 03.211.007

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) 2020 that the metal portion of the mesh plate cutters has broken during the sterile processing after a case.There was no patient involvement.This report is for one mesh plate cutters.This is report 1 of 1 for (b)(4).

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.H3, h6: a product investigation was conducted.Visual inspection: the mesh plate cutter (p/n: 03.211.007, lot #: 2769230) was returned and received at us cq.Upon visual inspection the plate holder component was observed to be broken and the broken fragment was lodged in the returned device.There were scratches on the device but has no impact on the functionality of the device.No other issues were identified with the returned components of the device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the mesh plate cutter (p/n: 03.211.007, lot #: 2769230).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.211.007, lot: 2769230, manufacturing site: bettlach , release to warehouse date: 18.August 2011, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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.

• Brand Name: MESH PLATE CUTTERS
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9744877
• MDR Text Key: 191317888
• Report Number: 2939274-2020-01014
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10886982076052
• UDI-Public: (01)10886982076052
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.211.007
• Device Catalogue Number: 03.211.007
• Device Lot Number: 2769230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1