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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
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).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 sales rep via email that during a rotator cuff repair on (b)(6) 2022, it was observed that the top jaw on the expressew iii autocapture flexible suture passer device was bent on.Another like device was used to complete the procedure with an unspecified minor delay.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 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.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 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.H10 additional narrative: investigation summary: according to the information received, it was reported that during a rotator cuff repair the top jaw of an expressew iii autocapture flexible suture passer was bent on.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.Upon visual inspection revealed wear marks on the device; also, the upper jaw was bent and loose when the jaws are closed, therefore, it showed that the jaws did not close normally contributing to the holding issue, the rest of the device is in normal condition.According with the visual inspection result, this complaint can be confirmed.The manufactured date of this device is 2015 and hence indicates this device is 8 years old.The possible root cause for the bent jaw can be attributed to the hard and continuous use of the device, since this device is reusable, the continuous use and sterilization process can cause metal fatigue leading to damages on the upper jaw.Holding issue could be related when clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually damage the jaw.However, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.

• 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: 15926591
• Report Number: 1221934-2022-03885
• Device Sequence Number: 5116112
• Product Code: LXH
• UDI-Device Identifier: 10886705025190
• UDI-Public: 10886705025190
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 30995-150220-08
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 01/09/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2015
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown