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

Model Number	391.952
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a synthes sales representative part 391.952, lot a7pa50: manufacturing site: (b)(4).Release to warehouse date: december 12, 2006.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.A service and repair evaluation was completed: the customer reported the device was not cutting correctly and it has a crack in it.The repair technician reported the device has piece missing from blade.Missing parts is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.A product investigation was completed: upon visual inspection, the cutting feature was observed to be broken and not returned.No other issues were observed with the returned device.A functional test was not performed as the device was returned by itself.However, the broken cutting blade could have caused the complaint condition.No dimensional inspection can be performed due to post-manufacturing damage.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition 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.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 the mesh cutter was not cutting correctly, and it has a crack in it.There was no report of patient or procedure involvement.Upon visual inspection of the returned device, the cutting feature was observed to be broken and not returned.This report is for a mesh cutter.This is report 1 of 1 for (b)(4).

• Brand Name: MESH 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: 11516665
• Report Number: 2939274-2021-01398
• Device Sequence Number: 14305887
• Product Code: HTZ
• UDI-Device Identifier: 10887587041001
• UDI-Public: (01)10887587041001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

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: 391.952
• Device Catalogue Number: 391.952
• Device Lot Number: A7PA50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/18/2021
• Patient Sequence Number: 1