MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS; ARTHROSCOPE

Catalog Number	283459
Medical Device Problem Codes	Mechanical Jam (2983); Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during device evaluation, it was determined that the inner shaft of the 4.0mm round burr device was seized, it was not possible to spin to any direction.It was noted in the service order that during a arthroscopic rotator cuff repair (arcr) for rotator cuff tears (rct) of the shoulder, the shaver had made a strange noise while in use, had stopped working, and was no longer usable.Even after changing the handpiece, it still wouldn't work, and even after changing the shaver tip, it stopped working again.The third shaver was still usable until the latter half of the operation.There were no 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 comes in used condition.The inner shaft was found seized, it was not possible to spin to any direction.No anomalies were found on the black connector.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 higher speeds applied on the handpiece which can increase the temperature of the device's shaft, lack of adequate irrigation and excessive side loading can contribute to a seized inner shaft, as per the instructions for use: adequate irrigation to the tip of the blade or burr is required to cool the blade and prevent accumulation of excised material in the surgical site.Excessive side loading may result in blade wear and degradation, as well as clogging and/or seizing.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 lot number (m2409003), and no non-conformance was identified.

• Brand Name: FMS
• 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 02767 ; 9083863534
• MDR Report Key: 24699152
• Report Number: 1221934-2026-01252
• Device Sequence Number: 10557154
• Product Code: HRX
• UDI-Device Identifier: 10886705025428
• UDI-Public: (01)10886705025428(10)M2409003(17)290831
• 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

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: M2409003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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