MAUDE Adverse Event Report: DEPUY MITEK LLC US CORDCUTTER *EA; CUTTER, SURGICAL

Catalog Number 214646

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

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

Event Date 01/01/2023

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.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.Visual observations revealed that the device had marks of wear near the handle and the metal on the inner as usual on these types of reusable devices.When performing the functional test, a sample suture was used, it was placed on the cutting hole, and it was difficult to cut the suture.A manufacturing record evaluation was performed for the finished device lot number (09a1), and no non-conformances were identified.According with the visual inspection result, this complaint can be confirmed.The manufactured date of this device is 2009 and hence indicates this device is 14 years old.The possible root cause for the condition can be attributed to the constant use of the device, the continuous sterilization process and excessive abuse of the device over time which would eventually lead to inner shaft failing.As stated on ifu; end of useful instrument life is generally determined by wear or damage from handling or surgical use.The precautions for this type of device consist of to inspect the condition of the device prior to use.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Udi: (b)(4).

Event Description

It was reported by the sales rep that during an unknown procedure on an unknown date, it was observed that the pin on the side of the cord cutter device was out.During in-house engineering evaluation, it was determined that the device would not cut/dull.It was unknown how the surgery was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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: 18519536
• MDR Text Key: 333096665
• Report Number: 1221934-2024-00114
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214646
• Device Lot Number: 09A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2009
• 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