MAUDE Adverse Event Report: DEPUY MITEK LLC US TENDON HARV CLOSED STRIPPER EA; BONE TREPHINE

Model Number	254730
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate in (b)(4) that preoperatively to an unknown surgery on (b)(6) 2022, it was observed that the tendon harv closed stripper device was bent and could not be used.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary = > upon visual inspection the device present wear use.It could be observed the shaft of the device with a bent and rotated condition.Also, it could be identified the etch marks slightly faded.A manufacturing record evaluation was performed for the finished device lot number: 17r04, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection results, this complaint can be confirmed.The manufactured date of this device is 2017 and hence indicates this device is 5 years old.It is a reusable device; this condition has possibly occurred after using it for many procedures.The possible root cause for the condition of the device could be related to heavily use; moreover, drop of the unit, mishandling or procedural variables that could cause the bent condition of the device.However, it cannot be conclusively affirmed.As per ifu, inspect for damage prior to use.Replace a damaged, worn or bent instrument.Do not attempt to straighten, sharpen or repair.Do not use a depuy mitek reusable instrument for any purpose other than its intended use as that may result in damage to the instrument.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: TENDON HARV CLOSED STRIPPER EA
• Common Device Name: BONE TREPHINE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14279379
• Report Number: 1221934-2022-01264
• Device Sequence Number: 5312685
• Product Code: LXH
• UDI-Device Identifier: 10886705013739
• UDI-Public: 10886705013739
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 254730
• Device Catalogue Number: 254730
• Device Lot Number: 17R04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 06/29/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/23/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown