MAUDE Adverse Event Report: DEPUY MITEK LLC US TENDONHARV TARGET HARVESTER *EA; BONE TREPHINE

Model Number	232004
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: background: equipment # 500055413 arrives, with the harvester tonotomo in pistol, with obvious damage and the part is out of service.The procedure was not affected, the client was not impacted by the incident given that they had the reference 254729, closed harvester tenotome.And the procedure was carried out without inconvenience.Investigation summary: the tendonharv target harvester *ea (part #: 232004, lot #: 1903001) was received and evaluated at us cq.Upon visual inspection, the inner sleeve weldment, tendon harvester was loose and didn't work as intended.The target disposable cutting tip is bent and deformed.Hence, the reported condition can be confirmed.No definitive root cause can be determined based on the provided information.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the tendonharv target harvester device had an unspecified damaged/malfunction.During in-house engineering evaluation, it was determined that the device was loose, did not work as intended, and the disposable cutting tip was bent and deformed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Common Device Name: BONE TREPHINE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12698498
• Report Number: 1221934-2021-03124
• Device Sequence Number: 3705974
• Product Code: NBH
• UDI-Device Identifier: 10886705010905
• UDI-Public: 10886705010905
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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: 232004
• Device Catalogue Number: 232004
• Device Lot Number: 1903001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1