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

Model Number 214140

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Difficult to Open or Close (2921); Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Investigation summary: according to the information provided, it was reported that this complaint has been created to receive blind unit for evaluation.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed marks of wear.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.A needle was loaded, it revealed that the needle deploy as normally, after several times the needle was not functioning as expected due to it was very hard to deploy causing stuck issue.The trigger had to be manually pushed back to retract the needle to its original position.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.

Event Description

It was reported that during in-house engineering evaluation, it was determined that the upper jaw was slightly loose when the jaws were closed; therefore, it showed that the jaws did not close normally contributing to the holding issue on the expressew iii w/o hook device.It was further determined that when a needle was loaded on the device, it revealed that the needle deploy as normally, after several times the needle was not functioning as expected due to it was very hard to deploy causing stuck issue.The trigger had to be manually pushed back to retract the needle to its original position on the device.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: EXPRESSEW III W/O HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12894395
• MDR Text Key: 285963988
• Report Number: 1221934-2021-03495
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2021

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: 214140
• Device Catalogue Number: 214140
• Device Lot Number: 56201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1