MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EXPRESSEW III AC+ GUN; 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 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown.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 the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the expressew iii ac+ gun device failed.According to the report, the clamp stayed stuck with the needle when passing the joint that it did not go down and became stuck in the tissue.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.

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: additional information: b5, d4: subsequent follow-up with the customer, additional information was received about the event and the lot number.Both fields have been updated accordingly to reflect this information.Udi: (b)(4).

Event Description

It was reported by the affiliate in colombia that during an arthroscopic rotator cuff reconstruction procedure on (b)(6) 2021, it was observed that the expressew iii ac+ gun device failed.According to the report, the clamp stayed stuck with the needle when passing the joint that it did not go down and became stuck in the tissue.Another like device was used to complete the procedure with a ten minute delay.There were no adverse patient consequences 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
• MDR Report Key: 11307690
• MDR Text Key: 232872682
• Report Number: 1221934-2021-00472
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: 10886705027101
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

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: 54082
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/19/2021; 04/20/2021
• Supplement Dates FDA Received: 02/24/2021; 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1