MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER; SUTURE/NEEDLE PASSER, REUSABLE

Model Number	214157
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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 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.Udi: (b)(4).The expiration date is currently unavailable.Initial reporter is a j&j sales representative.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
It was reported by the sales rep that during a rotator cuff repair procedure on (b)(6) 2023, it was observed that the grabber at the end of the expressew iii autocapture flexible suture passer device snapped while grabbing the tissue.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.
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 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.H6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 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: investigation summary = > the product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.Upon visual inspection, the lower jaw was broken from the shaft.A pin jaw-shaft was not attached.A manufacturing record evaluation was performed for the finished device lot number 23436-140514-05, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.It is possible that the shear pin within the device handle has failed, eliminating the link between the jaw lever and the actuator, preventing the jaw from functioning.This shear pin is a design feature to ensure that if excess tissue is clamped, link failure occurs within the handle and will prevent loose bodies from exiting the device; as it is a reusable device, the failure may have occurred after using it in this way for many procedures and could have been damaged before use.However, given the evidence we cannot discern a definitive root cause for the reported failure.As per ifu, do not use if product is damaged or sterile barrier is compromised.Also, inspect the expressew iii prior to use to ensure proper mechanical function; with the jaw closed, actuate the needle deployment lever once to confirm that the needle deploys and retracts.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• 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: 16504958
• Report Number: 1221934-2023-01100
• Device Sequence Number: 20407593
• Product Code: LXH
• UDI-Device Identifier: 10886705025190
• UDI-Public: 10886705025190
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 214157
• Device Catalogue Number: 214157
• Device Lot Number: 23436-140514-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 03/08/2023; 03/31/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 03/09/2023; 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown