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

Model Number 214140

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

It was reported by the sales rep that the jaw on the customer's expressew iii without hook was bent prior to an unknown procedure.The case was completed with another like device.There were no patient consequences or delays.The sales rep was not present during the case and could not provide any more details.The device is being returned.

Manufacturer Narrative

Product complaint # (b)(4).The complaint device was received and evaluated.Visual observations revealed that the upper jaw of the expressew gun was bent slightly towards one side contributing to jaw failure preventing it from closing completely.This complaint can be confirmed.Clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess side load on the upper jaw deforming it off from its shape.This failure can be attributed to user technique.A dhr review has been conducted on this manufacturing lot and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.At this point in time, 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.(b)(4).

• 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
• MDR Report Key: 7327936
• MDR Text Key: 102101386
• Report Number: 1221934-2018-50283
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705020218
• UDI-Public: (01)10886705020218(10)34979-151207
• 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: 03/13/2018

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: 34979-151207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1