MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III SUTURE PASSER W/O HOOK; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 214140

Device Problems Device-Device Incompatibility (2919); Difficult to Open or Close (2921)

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

Event Date 08/26/2022

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.Additional narrative: udi: (b)(4).The device manufacture date is currently unavailable.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 marks of use and a label was found in the handle.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 issue.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.According with the visual inspection 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-110114, 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.Device history lot: as a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.

Event Description

It was reported by the healthcare professional that the expressew iii suture passer w/o hook device was not closing all the way.During in-house engineering evaluation, it was determined that the upper jaw on the device was slightly loose when the jaws were closed; therefore, it showed that the jaws did not close normally contributing to the holding issue.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: EXPRESSEW III SUTURE PASSER W/O HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15670588
• MDR Text Key: 306920572
• Report Number: 1221934-2022-03297
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705020218
• UDI-Public: 10886705020218
• 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
• 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: 214140
• Device Catalogue Number: 214140
• Device Lot Number: 29853-14129-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1