MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III NEEDLE PK5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	214141
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
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 mitek or its employees that the report constitutes an admission that the device, 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.H11 additional narrative: 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.
Event or Problem Description
Report 1 of 3 for (b)(4).It was reported that during an arthroscopic rotator cuff repair while using a expressew iii needle device, exprsew iii ac+ rtn plate device and expressew iii ac+ gun device it was observed that the surgeon was able to pinch sutures with the retention plate but was unable to retrieve them, and they came off.According to the reporter, at first the surgeon used a suture (orthocord), but it snapped.The surgeon kept using the devices in question but could not apply sutures.Another like device was used to complete the procedure.When the sale rep checked the movement of the passer after the surgery, the passer moved without any problems.It was impossible to determine whether the retention plate, the needle, or the passer was the problem.There was no harm to the patient.There was a thirty minute delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
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 mitek or its employees that the report constitutes an admission that the device, 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.H11 additional narrative: the complaint device was discarded by the customer, therefore not returned to j&j medtech orthopaedics and unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (75631), and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.

• Brand Name: EXPRESSEW III NEEDLE PK5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 22825654
• Report Number: 1221934-2025-03150
• Device Sequence Number: 17281405
• Product Code: LXH
• UDI-Device Identifier: 10886705020225
• UDI-Public: (01)10886705020225(10)75631(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/18/2025

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 Catalogue Number: 214141
• Device Lot Number: 75631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown