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

Catalog Number 214140

Device Problems Bent (1059); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

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 expressew iii bent during a rotator cuff repair.There were no patient consequences or delays.The case was completed with another like device.The sales rep was not present during the case and could not provide any more details.The device is being returned.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was received and inspected visually and tested for its functionality.Visually, there are no anomalies found on the device.The complaint cannot be confirmed.All the parts seem intact and in good working condition.The device was mated with an expressew iii needle and tested on a sample rubber strip.The needle was deployed successfully and suture passed through the rubber strip.This procedure was repeated several times successfully to confirm the suture passer performed as intended.We cannot confirm the reported failure of this device at this point.A possible hypothesis for the reported failure would be during the procedure too much tissue was grabbed between the suture passer putting extra load on the needle to pass through it.However other than this possibility, we cannot discern a potential root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the (b)(4) complaints system revealed no other complaints of any type for this lot that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, (b)(4) 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.

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.Udi: (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: 7451557
• MDR Text Key: 106254149
• Report Number: 1221934-2018-50500
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982153821
• UDI-Public: 10886982153821
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2018

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 Catalogue Number: 214140
• Device Lot Number: 42328-170421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 05/17/2018; 10/03/2018
• Supplement Dates FDA Received: 06/12/2018; 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1