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  

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: e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.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.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Investigation summary: 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.A manufacturing record evaluation was performed for the finished device lot, and no nonconformances were identified.Based on missing screw, 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.

• 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: 18269770
• MDR Text Key: 329752338
• Report Number: 1221934-2023-04394
• 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

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: 22A15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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