MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIXADV PEEK ANC PCORD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	223134
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair procedure, after preparing the pilot hole in the humeral head, a 4.5 healixadv peek anc pcord anchor was inserted according to standard technique.Upon insertion, the anchor failed to maintain suture integrity.The sutures became detached from the bottom of the anchor, indicating a failure of the internal suture-retention mechanism.No external deformities, cracks, or material defects were noted on the outside of the anchor upon inspection.The appearance suggested that the internal bridge or internal suture-retention component may have failed.The anchor was subsequently discarded and was not available for return or further analysis.No patient injury was reported, and an alternative fixation method was used to complete the procedure.There was a five minute delay.The procedure was successfully completed.No additional medical intervention was required.
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: 4.5 HEALIXADV PEEK ANC PCORD
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24568079
• Report Number: 1221934-2026-01005
• Device Sequence Number: 8385047
• Product Code: MAI
• UDI-Device Identifier: 10886705024674
• UDI-Public: (01)10886705024674(10)TMXAPE(17)261031
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 223134
• Device Lot Number: TMXAPE
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown