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

Model Number 288233

Device Problem Difficult to Open or Close (2921)

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

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 device manufacture date is currently unavailable.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, the pin jaw to shaft is not in place.Finally, it could be detected the jaw latch mechanism broken.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 of the photo, this complaint can be confirmed.It is a reusable device; this condition has possibly occurred after using it for many procedures.The possible root cause for the condition of the device could be related to heavily use and procedural variables, such handling of the device or product interaction during procedure.However, it cannot be conclusively affirmed.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function.Visually inspect the instrument and check for damage and wear.Also, jaws and teeth should align properly 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.

Event Description

It was reported by a healthcare professional in india that during a rotator cuff repair procedure on an unknown date, it was observed that the expressew iii autocapture + suture passer device was getting locked and not retrieving nor opening.Another like device was used to complete the procedure.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.H10 additional narrative: investigation summary: both photo of the device and the actual complaint device were received and evaluated.Upon visual inspection of the photo, the pin jaw to shaft is not in place.Finally, it could be detected the jaw latch mechanism broken.According with the visual inspection of the photo, this complaint can be confirmed.It is a reusable device; this condition has possibly occurred after using it for many procedures.The possible root cause for the condition of the device could be related to heavily use and procedural variables, such handling of the device or product interaction during procedure.However, it cannot be conclusively affirmed.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function.Visually inspect the instrument and check for damage and wear.Also, jaws and teeth should align properly in accordance with the manufacturer¿s instructions.Upon visual inspection of the complaint device, it was observed to writing "ndk" near the handle and wear marks were found in the device.To test its functionality, it was tested on a sample rubber strip; as a result, the upper jaw was slightly loose when the jaws are closed; therefore, it showed that the jaws did not close normally contributing to the holding and close issue.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.According with the visual inspection of the complaint device and the functional test result, this complaint can be confirmed.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.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.Visually inspect the instrument and check for damage and wear.Also, jaws and teeth should align properly.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.H10 correction narrative: d4: the lot number has been updated to reflect the correct information.Udi: (b)(4).

• 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: 15302919
• MDR Text Key: 305506130
• Report Number: 1221934-2022-02610
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: 10886705027101
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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
• Device Operator: Health Professional
• Device Model Number: 288233
• Device Catalogue Number: 288233
• Device Lot Number: 61960-210628-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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