MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HEALIX ADVANCE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222424
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair for a rotator cuff tear, the healix advance was used according to the procedure manual, but the anchor was not fixed and dislodged.Another device was used to complete the procedure.There was surgical delay of under 30 minutes and no harm to the patient.It was confirmed that there were no remaining implants in the body.The device was brand new and the first use when the issue occurred.All available information has been disclosed.
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.

• Brand Name: HEALIX ADVANCE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; la locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25447969
• Report Number: 1221934-2026-02478
• Device Sequence Number: 9586955
• Product Code: MAI
• UDI-Device Identifier: 10886705030590
• UDI-Public: (01)10886705030590(10)10BL1T(17)280930
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191242
• 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

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: 222424
• Device Lot Number: 10BL1T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2025
• 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