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

Catalog Number	214646
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
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.E1: the reporter¿s complete facility address was not provided.
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair procedure that the handle of the cordcutter device was too stiff and difficult to use.Another device was used to complete the procedure.It was used for the first time after purchase.There were 30 minutes surgical delay and no harm to the patient.No further information is available.

• Common Device Name: CUTTER, SURGICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; IS
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24445557
• Report Number: 1221934-2026-00891
• Device Sequence Number: 10220686
• Product Code: FZT
• UDI-Device Identifier: 10886705004270
• UDI-Public: (01)10886705004270(10)INCOMPLETE
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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