MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW II FLEXIBLE SUTURE PASSER -NS; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 214004

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a rotator cuff repair the expressew ii flexible suture passer stopped working.The needle was not passing and the device was not clamping down.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.

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.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.H10 additional narrative: investigation summary: according to the information provided, it was reported that during a rotator cuff repair the expressew ii flexible suture passer stopped working.The complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [(b)(6)] number, and no non-conformances were identified.  since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Device history lot : a manufacturing record evaluation was performed for the finished device [(b)(6)] number, and no non-conformances were identified.

• Brand Name: EXPRESSEW II FLEXIBLE SUTURE PASSER -NS
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9580543
• MDR Text Key: 206740483
• Report Number: 1221934-2020-00142
• Device Sequence Number: 1
• Product Code: LXH
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Patient Sequence Number: 1