MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO PUSHER/CUTTER *EA; SUTURE CUTTER

Catalog Number 228302

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4)-incomplete.The lot number 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 a defective mitek arthroscopic pusher cutter was used on an meniscal repair case where the device prematurely cut the suture before the trigger was pushed.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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

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 initial medwatch, a follow-up medwatch will be filed as appropriate.The device is not being returned.The device is not available for physical evaluation and hence this complaint cannot be confirmed.Furthermore, no lot number was supplied which precludes conducting a device history record review or a lot specific search in the depuy synthes mitek 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.

• Type of Device: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7942298
• MDR Text Key: 123369363
• Report Number: 1221934-2018-54844
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705010172
• UDI-Public: 10886705010172
• 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: 09/10/2018

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: 228302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1