MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.9MM HEALX ADV SP BIOC ANCHOR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222422
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 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 for the finished device 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.E1: the reporters complete facility address was not provided.
Event or Problem Description
It was reported that during an unspecified surgical procedure the 4.9mm healx adv sp bioc anchor and the 5.5mm healx adv sp bioc anchor devices were being used when but was unable to secure it into the bone and they fell out.The surgery was completed using a different product.There were no surgical delay and no harm to the patient.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 2 for the same event.

• Brand Name: 4.9MM HEALX ADV SP BIOC ANCHOR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24293827
• Report Number: 1221934-2026-00652
• Device Sequence Number: 21191152
• Product Code: MAI
• UDI-Device Identifier: 10886705030576
• UDI-Public: (01)10886705030576(10)107PS1(17)280331
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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: 222422
• Device Lot Number: 107PS1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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