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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III W/HOOK; SUTURE/NEEDLE PASSER, REUSABLE
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DEPUY MITEK LLC US EXPRESSEW III W/HOOK; SUTURE/NEEDLE PASSER, REUSABLE Back to Search Results
Model Number 288233
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2021
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.Udi: (b)(4) incomplete 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 customer in (b)(6) that during a rotator cuff reconstruction procedure on (b)(6) 2021, it was observed that the expressew iii ac+ gun device appeared to be clogged or seized that the needle would no longer extend.Another like device was used to complete the procedure with a delay of around 30 minutes.There were no adverse patient consequences 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 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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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.Investigation summary: according to the information received, it was reported that during rotator cuff the device appears to be clogged or seized so the needle no longer extends.Impossible to use the device the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received by the customer.Visual observations revealed that the device was worn due to scratches and nicks were found in the entire device.The shear pin was loose, and the jaw mechanism was not working properly.The upper jaw was loose and slightly bent when the jaws are closed.To test its functionality, an eiii needle was loaded into the device and was tested on a sample rubber strip.When the trigger was actuated to deploy the needle, there was a slight resistance, and the deployment was rough causing stuck issue.To restore it to the original position, the needle trigger must be pushed back manually.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.Based on the results, this complaint can be confirmed.Previous investigation revelated 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.It is possible that the failure occurred due to excessive mechanical force while handling the device.Also, the possible root cause for deployment issue can be attributed an improper maintenance would lead to bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.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; and jaws and teeth should align properly.Also, it is necessary to follow the instructions to cleaning and sterilization process and between uses, lubricate moving parts with the water-solubel lubricant 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.
 
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Brand Name
EXPRESSEW III W/HOOK
Type of Device
SUTURE/NEEDLE PASSER, REUSABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key11349216
MDR Text Key232592898
Report Number1221934-2021-00601
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10886705027101
UDI-Public10886705027101
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number288233
Device Catalogue Number214124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2021
Date Manufacturer Received06/09/2021
Patient Sequence Number1
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