MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO PUSHER/CUTTER *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number 228302

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/27/2024

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.Device was used for treatment, not diagnosis.H10 additional narrative: udi: (b)(4).The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.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.Investigation summary
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> ¿the product has not returned to depuy synthes mitek, however photos were provided for review.¿ the photo investigation revealed that the arthro pusher/cutter *ea had wear mark, these wear marks were found in the handle, also the inner shaft was detached from the outer shaft.The overall complaint was confirmed as the observed condition of the arthro pusher/cutter *ea would contribute to the complained device issue.¿ based on the investigation findings, a potential cause could be traced to continuous use since this device is reusable, the continuous use and sterilization process can cause worn condition and the resistance reported by the costumer.As per ifu, visually inspect the instrument and check for damage and wear.Moveable parts should have smooth movement without excessive play, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

Event Description

It was reported by the healthcare professional in colombia that during an unknown surgical procedure on (b)(6) 2024, it was observed that the inside of the arthro pusher/cutter device came out while cutting the suture.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 18849605
• MDR Text Key: 337036165
• Report Number: 1221934-2024-00752
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705010172
• UDI-Public: 10886705010172
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 228302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1