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

Catalog Number	214646
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair on shoulder joint for rotator cuff tear, the cordcutter movement was poor, and it could not be used.Another product was used, and the surgery was completed successfully.There was 30 minutes surgical delay and no harm to the patient.No further information is available.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that it is in used condition as expected in reusable devices.No other anomalies were noted.When performing the functional test and before to place a test suture, then a sample suture was used, it was placed on the cutting hole and the lock lever was pressed, consequently the handle was closed, the suture was able to be cut.The device's handle movement was normal, no issues were detected.The overall complaint was not confirmed as the observed condition of the cordcutter *ea would have not contributed to the complained issues.Based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established since the device passed the functional test.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A manufacturing record evaluation was performed for the finished device 25e03 number, and no non-conformances were identified.

• Common Device Name: CUTTER, SURGICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23720664
• Report Number: 1221934-2025-04611
• Device Sequence Number: 15977670
• Product Code: FZT
• UDI-Device Identifier: 10886705004270
• UDI-Public: (01)10886705004270(10)25E03
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 214646
• Device Lot Number: 25E03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown