MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX ADVANCE PERMACORD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	223128
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgery, the healix advance permacord anchor broke in half after the first half turn of the inserter.Bone quality was normal, leading to believe it was an anchor issue.There was no patient consequence.There was no delay.Another device from a different lot was used to complete the procedure.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.
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 product was not returned to depuy synthes; however, a photo was provided for evaluation.Visual inspection of the returned photo the anchor still attached to the inserter, just as it was cracked at mid body.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the 4.5 healixadv br anc pcord would have contributed to the complained device issue.Based on the investigation findings, the possible root cause can be associated with off axis insertion and levering during insertion.As per instructions for use, 1) inserting the awl or drill to less than the specified depth, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.2) do not apply a bending force to the inserter.This can damage the anchor or inserter tip.3) apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.Properly handling and attention to the approved use of the device diminishes the risk of failure.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 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.Device history review: there was no non-conformance regarding this lot.

• Brand Name: HEALIX ADVANCE PERMACORD
• 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: 25517044
• Report Number: 1221934-2026-02598
• Device Sequence Number: 9993458
• Product Code: MAI
• UDI-Device Identifier: 10886705024803
• UDI-Public: (01)10886705024803(10)10BMTU(17)280930
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: 223128
• Device Lot Number: 10BMTU
• 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: 06/10/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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