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

Model Number 228302

Device Problem Failure to Cut (2587)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199); Not Applicable (3189); No Code Available (3191)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter is a mitek sales representative.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 meniscal repair procedure the truespan peek 0 degree would not deploy the first implant.When using the truespan peek 12 degree, trying to fire the second implant, the surgeon forced the trigger causing the handle to break and it would not release the second implant.No debris was left in the patient.The surgeon removed the first implant without any issue and went to use a second truespan peek 12 degree, the second implant would not deploy on the device.The surgeon did not force the trigger on the second 12 degree device.The surgeon removed the first implant without any issue.The procedure was completed with another 12 degree device.Also, during the same case their arthro pusher/cutter would not cut properly; the device was dull.They were able to use the device throughout the case.There was a surgical delay of four minutes and there was damaged to the meniscus from removing two implants.It was noted the cutter is over a year old and has seen heavy use in the field.The truespans were discarded but the cutter will be returning for evaluation.This report is for a arthro pusher/cutter.This is report 4 of 4 for (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.The complaint device was received and evaluated.Visually, the device appears worn and the laser markings are faded.When tested for its functionality, the trigger was found to be rough, indicating internal components are worn.After the suture was loaded, the device does not have a clean cut.This complaint can be confirmed.The device seems to be old and the reported failure can be attributed to fair wear and tear as well as heavy use in the field.However,the definitive root cause cannot be determined.No lot number was available which precludes in conducting a manufacturing record evaluation.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 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.Investigation summary: the complaint device was received and evaluated.Visually, the device appears worn and the laser markings are faded.When tested for its functionality, the trigger was found to be rough, indicating internal components are worn.After the suture was loaded, the device does not have a clean cut.This complaint can be confirmed.The device seems to be old and the reported failure can be attributed to fair wear and tear as well as heavy use in the field.However,the definitive root cause cannot be determined.No lot number was available which precludes in conducting a manufacturing record evaluation.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.

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.H10 additional narrative: correction: d10: the date device returned to manufacturer has been updated to reflect the correct information.H6: patient code: the field has been updated to reflect the correct information.3191 (no code available) was used to capture surgical intervention.

• Type of Device: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9205038
• MDR Text Key: 206792385
• Report Number: 1221934-2019-59067
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705010172
• UDI-Public: (01)10886705010172
• Combination Product (y/n): N
• 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: 09/19/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 11/15/2019; 09/30/2020; 10/04/2020
• Supplement Dates FDA Received: 11/18/2019; 10/02/2020; 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1