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

Catalog Number	222424
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2026
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 arthroscopic rotator cuff repair (arcr) surgical procedure, after the surgeon placed a third-party anchor medially, and a 5.5mm healx adv sp bioc anchor device was utilized to suture the rotator cuff and create a bridging construct.It was reported that the bone tunnel, which was created using a self-punch, was situated too close to the apex of the greater tuberosity; furthermore, its trajectory was slightly suboptimal.Consequently, it was determined that adequate fixation could not be achieved even with partial anchor insertion.As a result, the decision was made to abandon the anchor insertion attempt and withdraw the anchor that had already been partially inserted.It was reported that there was a concern that withdrawing the dilator would cause the bone tunnel to enlarge; therefore, the dilator was unavoidably left in place within the bone tunnel.A new anchor device was retrieved and utilized, with the anchor placement site adjusted to a more distal position.The procedure was completed without any further complications.There was no surgical delay and no harm to the patient.No further information is available.
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 complaint device was discarded by the customer, therefore not returned to depuy synthes and unavailable for a physical evaluation.A manufacturing record evaluation was performed and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported 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: HEALIX ADVANCE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 25284012
• Report Number: 1221934-2026-02190
• Device Sequence Number: 15949154
• Product Code: MAI
• UDI-Device Identifier: 10886705030590
• UDI-Public: (01)10886705030590(10)10A4AC(17)280731
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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: 10A4AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female