MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSSEW III AC GUN; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 214157

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

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.Udi: (b)(4) ¿ incomplete.The lot number is not currently available.

Event Description

It was reported that an expressew 3 auto capture was opened at the beginning of the case.It was noted that the top jaw was bent.We replaced it and continued preparing for the case.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

Manufacturer Narrative

Product complaint # (b)(4).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 information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.

• Brand Name: EXPRESSSEW III AC GUN
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7554833
• MDR Text Key: 109755281
• Report Number: 1221934-2018-51071
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705025190
• UDI-Public: 10886705025190
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/05/2018

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: 214157
• Initial Date Manufacturer Received: 05/05/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1