MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 2.7MM MINI ULTRA-AGGR PLUS 5PK; ARTHROSCOPE

Catalog Number	283229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
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.Device was used for treatment, not diagnosis.H11: additional narrative: investigation summary = > the product has not returned to j&j medtech orthopaedics, however photos were provided for evaluation.Visual inspection of the returned photos found the inner shaft of the device broken and missing a part.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the 2.7mm mini ultra-aggr plus 5pk would contribute to the complained device issue.Based on the investigation findings, the potential cause can be 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.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 surgical procedure, it was discovered that the 2.7mm mini ultra-agger plus 5pk device snapped while in use.It was not reported if there were any delays to the surgical procedure or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.

• Brand Name: 2.7MM MINI ULTRA-AGGR PLUS 5PK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21562464
• Report Number: 1221934-2025-00898
• Device Sequence Number: 19941073
• Product Code: HRX
• UDI-Device Identifier: 10886705027194
• UDI-Public: (01)10886705027194(10)A2107014(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 283229
• Device Lot Number: A2107014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2021
• 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