MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTGRASPER 60 DEG *EA; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 251723

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem Not Applicable (3189)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) - incomplete.The exp date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(6) that during arthroscopic rotator cuff repair surgery, it was observed by the surgeon that the wire in the device had already been broken and it could not grasp the suture at all.According to the reporter, the issue was observed when the surgeon opened the packaged.The surgery was completed within a 30 minutes delay although it was not reported how the surgery was finished.There was no adverse consequence to the patient.It was brand new and the first use when the issue occurred.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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.If additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.No nonconformances were identified for this part-lot number combination.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8025412
• MDR Text Key: 125792103
• Report Number: 1221934-2018-55152
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705012312
• UDI-Public: 10886705012312
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

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: 251723
• Device Lot Number: L926675
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 11/03/2018
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1