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

Model Number 228302

Device Problem Dull, Blunt (2407)

Patient Problem Not Applicable (3189)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 via phone that during a meniscal repair the arthroscopic pusher/cutter was chewing on the suture but not cutting it.Another device was used to complete the procedure.An unspecified amount of time was used to get another device.No patient consequences reported.The device will 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: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: investigation summary
=
> according to the information provided, it was reported that during a meniscal repair the arthroscopic pusher/cutter was chewing on the suture but not cutting it.The complaint device was received and evaluated.Visual observations confirm that the device showed marks and appears worn, indicating device was used.When the trigger was tested, it feels rough as though the internal components are worn.When thread was loaded to test its functionality, it does not cut the suture cleanly, confirming this complaint.This device is more than ten months since its date of manufacture; thus, the possible root cause for the reported failure could be attributed to fair wear and tear of the device from repeated use and sterilization cycles.However; this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [19c06] number, and no non-conformances were identified.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 [19c06] number, and no non-conformances were identified.

• Type of Device: SUTURE KNOT PUSHER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9814317
• MDR Text Key: 201879051
• Report Number: 1221934-2020-00818
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

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 Model Number: 228302
• Device Catalogue Number: 228302
• Device Lot Number: 19C06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 05/06/2020; 06/08/2020
• Supplement Dates FDA Received: 05/07/2020; 06/09/2020
• Patient Sequence Number: 1