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

Model Number 214646

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

This is report 4 of 5 for (b)(4).It was reported through in-house distribution that while organizing the shelves, it was observed that the cord cutter device was broken.There was no procedure nor patient involvement reported.No additional information was provided.

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.H10 additional narrative: udi: (b)(4) incomplete.The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.E3: reporter is a j&j employee.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 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.H10 additional narrative: d4: the lot number was unknown on the initial report; and has been updated accordingly.Therefore, udi: (b)(6).

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.H10 additional narrative: investigation summary: the device was received and evaluated.On visual inspection, the device comes in used condition as expected.No breakage was observed.The device's handle works well, no obstructions were identified.The inner shaft was not returned; therefore, the functional test cannot be performed.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.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint cannot be confirmed.Since no breakage was found and the inner shaft was not returned, we are unable to perform a functional test, therefore, we cannot provide a root cause.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.

• Brand Name: CORDCUTTER
• Type of Device: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16994558
• MDR Text Key: 315864241
• Report Number: 1221934-2023-02141
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 7H4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1