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

Catalog Number	214141
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the needle was lodged inside of the expressew iii w/o hook.The needle tip was broken.The broken fragment of the tip was not returned for evaluation.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the expressew iii needle pk5 would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device.It is possible that the needle was not inserted in the correct way and therefore caused the needle to get jammed.As per the instructions for use, 1) inspect for damage to product or sterile barrier in the case of the disposable needle.Do not use if product is damaged or sterile barrier is compromised.2) inspect the expressew iii flexible suture passer prior to use to ensure proper mechanical function.3) steam sterilize the flexible suture passer according to the instructions in the sterilization section in the instructions for use.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.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 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.
Event or Problem Description
It was reported that during service and evaluation, it was observed that the expressew iii needle device needle tip was broken.It was noted in the service order that needle device was stuck inside the hook device and could not be removed.Another device was used to complete the procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.

• 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 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 23350714
• Report Number: 1221934-2025-04000
• Device Sequence Number: 7957280
• Product Code: LXH
• UDI-Device Identifier: 10886705020225
• UDI-Public: (01)10886705020225(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 214141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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