MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO SIXTER-LEFT *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number 214643

Device Problems Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

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: the product was returned to depuy synthes mitek for evaluation.Depuy synthes mitek then conducted visual inspection of the devices received.The device was received and evaluated.Upon visual inspection, it was observed that the device is in used condition.Under magnification of the sharp tip, it as observed that it is noticeably bent which cause an obstruction to the jaw, therefore it could not be opened or closed.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the arthro sixter-left *ea would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life.As per ifu end of useful instrument life is generally determined by wear or damage from handling or surgical use.Inspect instruments between uses to verify proper functioning.Therefore it has been determined, 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.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.H4: the date of manufacture was unknown.(b)(4).

Event Description

It was reported by the affiliate in ireland that during service and repair, it was determined that arthro sixter-right *ea device was defective.During in-house engineering evaluation, it was determined that the sharp tip was noticeably bent which caused an obstruction to the jaw, therefore it could not be opened or closed.There was no procedure involved.No additional information was provided.

• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19087074
• MDR Text Key: 339901005
• Report Number: 1221934-2024-01171
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705004249
• UDI-Public: 10886705004249
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 214643
• Device Lot Number: 23C02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1