MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EXPRESSEW III AUTOCAPTURE + SUTURE PASSER; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 288233

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2022

Event Type  malfunction  

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.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 Description

It was reported by a healthcare professional that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the plate on the expressew iii autocapture + suture passer device was not sitting correctly and not firing.Another like device was used to complete the procedure with an unspecified small delay.There were no adverse patient consequence reported.No additional information was provided.

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: 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.

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.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received visual observations revealed that the device had slightly marks of wear, but it was in expected condition.The plate retention was in place.To test its functionality, it was tested on a sample rubber strip and a needle; as a result, it revealed that the needle deploys as normally, the plate was releasing the needle and suture correctly; after several times there was a slight resistance, and the deployment was slightly rough.A manufacturing record evaluation was performed for the finished device 58414, and no non-conformances were identified.Based on the functional test, this complaint can be confirmed.The maintenance conditions of the device is unknown, the possible root cause of reported failure could be attributed to an improper maintenance during cleaning/ sterilization cycle would lead to bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.Since this is a reusable device and this failure has possibly occurred after using it in this manner for many procedures.However, this cannot be conclusively affirmed.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.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 + SUTURE PASSER
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15176017
• MDR Text Key: 304997322
• Report Number: 1221934-2022-02392
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: 10886705027101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 288233
• Device Catalogue Number: 288233
• Device Lot Number: 58414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1