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

Model Number 288233

Device Problems Difficult to Open or Close (2921); Migration (4003)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations revealed that the device had marks of wear.It observed that the jaws did not open/close normally contributing to the holding failure; besides, the upper jaw was loose when the jaws are closed.It was not possible to test its functionality due to it did not correctly hold the sample rubber strip and it is not fully functional.The pin jaw/shaft was missing.Therefore, this complaint can be confirmed.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.Upon further investigation it was found that the shear pin inside the handle of the device had failed, eliminating the linkage between the jaw lever and the actuator, preventing functionality of the jaw.This shear pin is a design feature to ensure that the tissue is clamped and prevent loose bodies from leaving the device the possible root cause for the issue experienced can be attributed 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; also, it is possible that the failure occurred due to excessive mechanical force while handling the device.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.However, it cannot be conclusively affirmed.As per ifu, when position the jaws and close the jaw it is necessary to secure but gentle grasp.If too much force is used to grasp tissue, passage of the needle and suture will be impeded.Also, it is necessary to follow the instructions of any cleaning and the recommendation of the proper condition during the sterilization and maintenance to avoid any damage.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.

Event Description

It was reported by the sales rep that during a rotator cuff repair surgery on (b)(6) 2021, it was observed that the jaws on the expressew iii ac+ gun device would not close completely.During in-house engineering evaluation, it was determined that there marks of wear, jaws did not open/close normally contributing to the holding failure, upper jaw was loose when the jaws were closed, did not correctly hold the sample rubber strip, and the pin jaw/shaft was missing on the device.The procedure was completed with the same device.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: EXPRESSEW III AC+ GUN
• 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 Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13336821
• MDR Text Key: 285004047
• Report Number: 1221934-2022-00271
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• 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: 58322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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