MAUDE Adverse Event Report: DEPUY MITEK LLC US CORDCUTTER; SUTURE CUTTER

Model Number 214646

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

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

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 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.Udi: (b)(4).D4: the expiration date is currently unavailable.E3: reporter is a j&j sales representative.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.The device was received and evaluated.Visual observations revealed that the device shows wear mark, these wear marks were found in the distal part of the inner shaft as well as the proximal part, no structural anomalies were found in the outer shaft.When performing the functional test, a sample suture was used, it was placed on the cutting hole and the trigger was pressed, difficult to cut was noted due to resistance was felt when actioned the trigger, however the device was able to cut.A manufacturing record evaluation was performed for the finished device 15p09 number, and no non-conformances were identified.According with the visual inspection and the functional test result, this complaint can be confirmed.The manufactured of the device was 2015 hence indicates this device is 8 years old.The possible root cause can be attributed to the constant use of the device, the continuous sterilization process and the age of the device can lead to wear in the device components and consequently the damage of the device.As stated on ifu 108484: end of useful instrument life is generally determined by wear or damage from handling or surgical use.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.

Event Description

It was reported by the sales rep that the cordcutter device was found damaged in the warehouse.During in-house engineering evaluation, it was determined that the device had difficulty cutting the suture when performing the functional test.According to the investigation, resistance was felt when the trigger was pressed although the device was able to cut.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: CORDCUTTER
• Type of Device: SUTURE CUTTER
• 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: 17200199
• MDR Text Key: 318036396
• Report Number: 1221934-2023-02518
• Device Sequence Number: 1
• Product Code: FZT
• UDI-Device Identifier: 10886705004270
• UDI-Public: 10886705004270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214646
• Device Catalogue Number: 214646
• Device Lot Number: 15P09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1