MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO SUTURE CUTTER SLIDING *EA; CUTTER, SURGICAL

Catalog Number 214627

Device Problems Degraded (1153); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2023

Event Type  malfunction  

Event Description

It was reported by the sales rep in colombia that during an unspecified surgical procedure performed on (b)(6) 2023 it was observed that two arthro suture cutter sliding *ea devices were missing a screw and could not be used, and it was very hard to cut with the devices.There were no reported adverse patient consequences.There was a unspecified surgical delay reported.No additional information was provided.This is report 1 of 2 for the same event in (b)(4).

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.Device was used for treatment, not diagnosis.E3: reporter is a j&j sales representative.Udi:(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

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: the investigation has been updated to reflect the correct information: investigation summary - according to the information received, it was reported that it lacks a screw, which prevents its use.Open reference, don't cut is very hard.Increased surgical time.Photos were returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photos.Visual analysis of the photos revealed that a screw in the handle was missing; this may cause that the mechanism of the device to malfunction.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Based on the visual findings, this complaint can be confirmed.The possible root cause for the condition of the device could be attributed to the constant use of the device, the continuous sterilization process and the age of the device.As per ifu; end of useful instrument life is generally determined by wear or damage from handling or surgical use.Inspect instruments between uses to verify proper functioning.It is the responsibility of the end user to ensure that the cleaning and sterilization is actually performed using appropriate equipment, materials, and personnel to achieve the desired result.Inspect all instruments before sterilization or storage to ensure the complete removal of soil from surfaces, tubes and holes, moveable parts.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

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.H6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary the products were returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of the devices received.The device was received for evaluation.Upon visual inspection, it was observed that it shows noticeable wear marks, as expected in this type of reusables devices.The screw that retains the inner shaft was missing, due to this the functional tests could not be performed.The observed condition was identified as an end-of-life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A manufacturing record evaluation was performed for the finished device lot number: 21r03, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the arthro suture cutter sliding *ea would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to procedural variables or product interaction during cleaning and sterilization process; the device could have not been correctly reassembled.As per ifu; open handles until position is locked by tooth in ratchet.Removable rod; unscrew and remove knurled pin.Slide out rod.Do not force.Part way out, a 1/4 turn of the rod may be necessary for free sliding.Clean rod and handles with tube separately, preferably in an ultrasonic cleaner, using a mild ph-neutral solution.After cleaning, rinsing, and drying, assemble in reverse order.Also, end of useful instrument life is generally determined by wear or damage from handling or surgical use.Inspect instruments between uses to verify proper functioning.Therefore, it has been determined, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Type of Device: CUTTER, SURGICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18269577
• MDR Text Key: 329751132
• Report Number: 1221934-2023-04392
• Device Sequence Number: 1
• Product Code: FZT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214627
• Device Lot Number: 21R03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1