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	09/23/2022
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).The expiration date is currently unavailable.Reporter is a j&j sales representative.The device manufacture date is currently unavailable.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
This is report 1 of 2 for (b)(4).It was reported by the sales rep that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the expressew iii autocapture flexible suture passer device was bending the needle.Another like device was used to complete the procedure with a delay of five minutes.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.H1 additional narrative: investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed wear marks and no needle was received long with the gun.Also, the upper jaw was loose; therefore, it showed that the jaws did not close normally contributing to the holding and deployment issue.No damage or bent condition was found in the gun.To test its functionality, a needle test was loaded into the device and was tested on a sample rubber strip.When the trigger was actuated to deploy the needle, there was a slight resistance, and the deployment was rough causing stuck issue.To restore it to the original position, the needle trigger must be pushed back manually.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.According with the results, this complaint cannot be confirmed.The possible root cause for deployment issue can be attributed an improper maintenance would lead to bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.For the jaw condition could be related when the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually damage the jaw.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function.Also, it is necessary to follow the instructions to cleaning and sterilization process and between uses, lubricate moving parts with the water-soluble lubricant in accordance with the manufacturer¿s instructions.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.
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.D9, h3, 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.

• 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: 15563108
• Report Number: 1221934-2022-03074
• Device Sequence Number: 17785888
• Product Code: LXH
• UDI-Device Identifier: 10886705025190
• UDI-Public: 10886705025190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 30394150211-07
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 11/06/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/14/2022; 11/07/2022
• 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