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

Catalog Number	283459
Medical Device Problem Codes	Break (1069); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
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.Device was used for treatment, not diagnosis.H11 additional narrative: e3: reporter is a j&j sales representative.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 from switzerland that during an arthroscopic surgical procedure it was observed that after a short period of use, the 4.0mm round burr plus shaver with the burr stopped working.It was reported that the burr attachment was disconnected from the shaver handpiece, and fine broken plastic particles could be seen on the connecting piece between the shaver handpiece and the burr.It was reported that the generated fragments did not come into contact with the patient.The procedure was successfully completed with a new burr.There were no adverse consequences to the patient.No additional information could be provided.
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.Device was used for treatment, not diagnosis.D10.Concomitant med products and therapy dates: shaver handpiece device.Additional information b5: additional information received from the affiliate states that there was no issue with shaver hand piece, this was checked by visual inspection and worked without any issue with a new burr.
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.Device was used for treatment, not diagnosis.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 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.Device was used for treatment, not diagnosis.Investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection found that 4.0mm round burr plus 5pk had the tip of the inner shaft nicked and the outer shaft had foreign matter particles, presumably metal debris upon visualization under magnification.The overall complaint was confirmed as the observed condition of the 4.0mm round burr plus 5pk would contribute to the complained device issue.Based on the investigation findings, the potential cause can be traced to blade wear and degradation.As per instructions for use (ifu), excessive side loading may result in blade wear and degradation.Adequate suction is recommended to reduce wear and degradation of the device, and 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.Device history lot: a manufacturing record evaluation was performed for the finished device, and no non-conformances were 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 (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21028450
• Report Number: 1221934-2024-04655
• Device Sequence Number: 9180664
• Product Code: HRX
• UDI-Device Identifier: 10886705025428
• UDI-Public: (01)10886705025428(10)M2205025(17)270430
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: M2205025
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 01/29/2025; 01/31/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/16/2025; 01/30/2025; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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