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

Catalog Number	283459
Medical Device Problem Codes	Infusion or Flow Problem (2964); Output Problem (3005); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
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.
Event or Problem Description
It was reported that during a arthroscopic rotator cuff repair (arcr) on the shoulder for rotator cuff tear, it was observed that the suction of the 4.0mm round burr plus system suddenly stopped working.It was reported that the surgeon stopped using the device and separated the inner and outer tubes.It was observed that a thin, transparent, rubber-like membrane attached to the outer surface of the inner tube had gathered at the distal end, and it appeared that this blockage between the inner and outer tubes was the reason the suction stopped working.Furthermore, when attempting to reinsert the inner cylinder into the outer cylinder, the gathered portion obstructs the process, making it impossible to return it to its original position.A replacement unit for the same product was opened and used.The surgeon noted that when using the product, centrifugal force causes the thin transparent rubber membrane attached to the middle tube to be pushed distally and gathered, which may result in the shaver making a strange noise and stopping or becoming unable to produce suction.There was 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: 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.
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: investigation summary: the complaint device was not returned to depuy synthes, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and 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.
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: investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found it with signs of usage.Additionally, the transparent membrane covering the inner sleeve was deformed and broken, therefore a fragment of it was no longer attached to the sleeve.No other anomalies could be observed.A functional test was performed; the device was assembled in the outer sleeve, but resistance was felt when trying to assemble and disassemble the device.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.It is possible that the inner sleeve was disassembled of the out blade when the device was hot due to the operation of the fms handpiece.As per the instructions for use (ifu): 1) 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.2) to prevent damage, do not allow blade or burr to come in contact with other instruments and/or implants while rotating.3) excessive side loading may result in blade wear and degradation, as well as clogging and/or seizing.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.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.Device history review a manufacturing record evaluation was performed for the finished device lot number, 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 02767 ; 9083863534
• MDR Report Key: 23990948
• Report Number: 1221934-2026-00103
• Device Sequence Number: 16086096
• Product Code: HRX
• UDI-Device Identifier: 10886705025428
• UDI-Public: (01)10886705025428(10)M2409003(17)270228
• 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,Followup,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: 283459
• Device Lot Number: M2409003
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 01/22/2026; 01/23/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/13/2026; 01/23/2026; 01/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown