MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.0MM ROUND BURR PLUS 5PK; ARTHROSCOPE

Catalog Number	283459
Medical Device Problem Codes	Degraded (1153); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair (arcr) on shoulder for rotator cuff tear surgical procedure it was observed that the 4.0mm round burr plus 5pk device suddenly locked and could no longer be used.In order to grind the bone, the round burr device was pressed against the bone, and it was assumed that this put stress on the base of the bur.However, the cause was unknown.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.
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.
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 it with signs of usage.Additionally, the inner shaft was jammed, and it was not possible to spin in any direction or disassemble the device.No other anomalies could be observed.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the 4.0mm round burr plus 5pk would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.Higher speeds applied on the handpiece can increase the temperature of the device's shaft.Lack of adequate irrigation and excessive side loading can contribute to a seized inner shaft.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 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, and no non-conformance was identified.

• Brand Name: 4.0MM ROUND BURR PLUS 5PK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA ; 9083863534
• MDR Report Key: 23936966
• Report Number: 1221934-2025-05039
• Device Sequence Number: 9611331
• Product Code: HRX
• UDI-Device Identifier: 10886705025428
• UDI-Public: (01)10886705025428(10)M2306022(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131191
• 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
• Report Date (Section B): 12/31/2025

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: 283459
• Device Lot Number: M2306022
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown