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

Catalog Number	283459
Medical Device Problem Codes	Use of Device Problem (1670); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: device history review a manufacturing record evaluation was performed for the finished device lot number (m2306007), and no non-conformance was identified.Investigation summary the product was returned to j&j medtech orthopaedics for evaluation.¿ visual inspection revealed that the inner shaft was jammed and was unable to be disassembled.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 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.As per ifu, do not bend blade or burr, to prevent damage, do not allow blade or burr to come in contact with other instruments and/or implants while rotating.Additionally, excessive side loading may result in blade wear and degradation.Adequate suction is recommended to minimize clogging, reduce build-up of excised material in the joint, and reduce wear and degradation of the device.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 j&j medtech orthopaedics 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.
Event or Problem Description
It was reported that during an unspecified elbow surgery, it was observed that the 4.0mm round burr plus 5pk device did not work.Another like device was used to complete the procedure.During in-house engineering evaluation, it was determined that the device inner shaft was jammed and was unable to be disassembled.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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 (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 22901946
• Report Number: 1221934-2025-03308
• Device Sequence Number: 18414367
• Product Code: HRX
• UDI-Device Identifier: 10886705025428
• UDI-Public: (01)10886705025428(10)M2306007(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
• Report Date (Section B): 08/27/2025

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: M2306007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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