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

Model Number 228302

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a mitek sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

It was reported that during a knee scope procedure the arthroscopic pusher/ cutter was cutting fine but going to get the fourth suture, the device would not cut the suture.The procedure was completed with another like device with no patient harm or surgical delay to the case.The device will be returning for evaluation.This report is for an arthroscopic pusher/cutter.This is report 1 of 1 for (b)(4).

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.Investigation summary : the complaint device was received and inspected.Visually, the device appears worn indicating device was used, but as expected condition and the laser markings are slightly faded.Under magnification, the distal end of the cutter has nicks and marks.When the trigger was tested, it feels rough as though the internal components are worn.When suture was loaded to test its functionality, it does not cut the suture cleanly, confirming this complaint.A manufacturing record evaluation was performed for the finished device lot number on 11-27-2019, and no non-conformances were identified.This device is about than four years old and its failure could be attributed to field wear.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.Udi(b)(4).

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Manufacturer Narrative

This report is being submitted in 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.Method codes: a manufacturing record evaluation was performed for the finished device lot number on 11-27-2019, and no non-conformances were identified.Investigation summary the complaint device was received and inspected.Visually, the device appears worn indicating device was used, but as expected condition and the laser markings are slightly faded.Under magnification, the distal end of the cutter has nicks and marks.When the trigger was tested, it feels rough as though the internal components are worn.When suture was loaded to test its functionality, it does not cut the suture cleanly, confirming this complaint.A manufacturing record evaluation was performed for the finished device lot number on 11-27-2019, and no non-conformances were identified.This device is about than four years old and its failure could be attributed to field wear.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: 9239589
• MDR Text Key: 208117687
• Report Number: 1221934-2019-59224
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705010172
• UDI-Public: (01)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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2019

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: 15P01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 12/12/2019; 08/07/2020
• Supplement Dates FDA Received: 11/22/2019; 12/16/2019; 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1