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

Model Number 214124

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.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 provided, it was reported that the jaws of the expressew iii suture passer w/ hook were not opening.The complaint device was received and evaluated.Visual observations reveal the device is slightly worn, used but in expected condition.When the trigger was actuated to close and open the jaw, there was slight resistance.The upper jaw was loose when the jaws need to close; besides, it was not opening properly.It observed that jaws doesn't close normally contributing to the holding sample, therefore the functionality test with the needle was not performed.This complaint can be confirmed.This type of failure is typically observed when clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually break.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required at this point in time, based on the overall complaint rate for this failure mode, 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.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that the jaws of the expressew iii suture passer w/ hook are not opening.The rep does not have more information.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.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 provided, it was reported that the jaws of the expressew iii suture passer w/ hook were not opening.The complaint device was received and evaluated.Visual observations reveal the device is slightly worn, used but in expected condition.When the trigger was actuated to close and open the jaw, there was slight resistance.The upper jaw was loose when the jaws need to close; besides, it was not opening properly.It observed that jaws doesn't close normally contributing to the holding sample, therefore the functionality test with the needle was not performed.This complaint can be confirmed.This type of failure is typically observed when clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually break.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required at this point in time, based on the overall complaint rate for this failure mode, 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.

• 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 Key: 9924712
• MDR Text Key: 206352838
• Report Number: 1221934-2020-01077
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705003655
• UDI-Public: 10886705003655
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214124
• Device Catalogue Number: 214124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 04/03/2020
• Patient Sequence Number: 1