MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CRVD MULTI BLADE 4.2MM 5PK; ARTHROSCOPE

Catalog Number	283432
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
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 an unspecified surgical procedure, while using the crvd multi blade 4.2mm device it was observed that the shaver blade suddenly became stiff.It was reported that after inspecting the device it was revealed that a piece was broken off.There were no reported adverse consequences to the patient, or surgical delay reported.No additional information could be 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: investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the inner shaft was broken, and its tip was jammed into the outer shaft.No other anomalies were noted.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 crvd multi blade 4.2mm 5pk would have contributed to the complained device issue.The possible root cause can be associated with blade wear and degradation.As per the instructions for use (ifu): 1) to prevent damage, do not allow blade or burr to come in contact with other instruments and/or implants while rotating.2) 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.

• Brand Name: CRVD MULTI BLADE 4.2MM 5PK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24337650
• Report Number: 1221934-2026-00744
• Device Sequence Number: 9781616
• Product Code: HRX
• UDI-Device Identifier: 10886705025961
• UDI-Public: (01)10886705025961(10)194L165(17)281031
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 283432
• Device Lot Number: 194L165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown