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

Catalog Number 214124

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

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 with hook was bent during a rotator cuff repair causing the suture to get stuck in the jaw.The sales rep also reported that the customer's 4220-3 hci s&n pow/pow max -ns interface cable had a damaged connector.There were no patient consequences or delays.The case was completed with other like devices.The expressew is being returned.The 4220-3 hci s&n pow/pow max -ns was discarded.

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.No further information regarding the technique 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.Device history lot: review of device history record revealed no anomalies.

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.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).

Event Description

Additional information received from affiliate on 31july2018: the complaint device is not available to be returned for evaluation.

• Brand Name: EXPRESSEW III W/HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7432213
• MDR Text Key: 105658352
• Report Number: 1221934-2018-50459
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2018

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: 214124
• Device Lot Number: 4428-110105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 07/31/2018; 10/26/2018
• Supplement Dates FDA Received: 10/25/2018; 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1