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

Model Number 288233

Device Problems Material Deformation (2976); Unintended Movement (3026)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

It was reported by the sales rep in colombia that during an unknown surgery on (b)(6) 2022, it was observed that when the expressew iii autocapture + suture passer device was twisted.During in-house engineering evaluation, it was determined that the upper jaw was loose; and would not close completely when the trigger was fully depressed.There were no adverse patient consequences nor surgical delay 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.Udi: (b)(4).The expiration date is currently unavailable.Initial reporter occupation: reporter is a j&j sales representative.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it was observed that the device does not show any structural anomalies.Wear marks could be found.Upon reviewing the upper jaw, it was found that is loose, when the trigger was fully depressed, the jaw cannot be closed completely.Due to the condition of the jaws a functional test cannot be performed.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.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for the loose jaw can be attributed to procedural variables, such handling of the device or product interaction during procedure, a bigger portion of tissue may have been grabbed and forced the jaw to close, also, since this device is reusable, the continuous use and sterilization process can cause metal fatigue leading to a non-closing jaw, however, this cannot be conclusively determined.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function and do not use if product is damaged.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals 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: 16702576
• MDR Text Key: 312897942
• Report Number: 1221934-2023-01529
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: 10886705027101
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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
• Device Operator: Health Professional
• Device Model Number: 288233
• Device Catalogue Number: 288233
• Device Lot Number: 58965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1