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

Model Number	391.952
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part number: 391.952, lot number: t936211, manufacturing site: (b)(4), release to warehouse date: 17-jul-2009.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: the mesh cutter (p/n: 391.952, lot #: t936211) was returned and received at us customer quality (cq).Upon visual inspection, the cutting jaw was observed to be broken and the broken fragment was not returned.There were scratches and discoloration was observed on the device but have no impact on the device functionality.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Service and repair evaluation the customer reported the device will not cut.The repair technician reported the distal tip was broken.Cutting jaws broken 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.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed: mesh plate cutter.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the mesh cutter (p/n: 391.952, lot #: t936211).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 on (b)(6) 2020, an inventory check occurred and multiple devices including a mesh cutter, right angle bender, plate cutter, 90 degree screwdriver t-handle, handle for 90° screwdriver, shaft for 90° screwdriver, and matrixrib screwdriver blade self-retaining f/90° screwdriver were found with malfunctions.When tested, the devices would not work properly.They would not turn, hold screws, and some were stripped.Some instruments were bent or dull.There was no patient or procedure involvement.This report is for one (1) mesh cutter.This is report 9 of 9 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 CUTTER
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10706281
• Report Number: 2939274-2020-04739
• Device Sequence Number: 11695705
• Product Code: HTZ
• UDI-Device Identifier: 10887587041001
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: T936211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 10/23/2020
• Patient Sequence Number: 1