MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX PEEK ANCH.W/OCORD; SCREW, FIXATION, BONE

Catalog Number	222205
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
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: ¿ the product has not returned to depuy synthes, however a photo was provided for review.¿ visual inspection of the returned photo found that the anchor was still attached to the inserter.The anchor was broken at the distal end.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the 4.5 healix peek anch.W/ocord would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause can be associated with off axis insertion and levering during insertion.As per ifu, inserting the awl less than the specified depth, axial misalignment or levering with the anchor upon insertion, may result in anchor fracture, and 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.
Event or Problem Description
It was reported that during an achilles repair surgical procedure it was observed that the 4.5 healix peek anch.W/ocord device anchor broke off.All broken parts were removed.Another like device was used to complete the procedure.There was a five minute delay in the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.
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.Investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection found that the anchor was broken at the distal end and still attached to the inserter.The overall device surface had foreign matter, presumably biological residue.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the 4.5 healix peek anch.W/ocord would have contributed to the complained device issue.Based on the investigation findings, the potential cause for the broken anchor can be traced to off axis insertion and levering during insertion.As per ifu- 109139 inserting the awl less than the specified depth, axial misalignment or levering with the anchor upon insertion, may result in anchor fracture.Do not apply a bending force to the inserter.This can damage the anchor or inserter tip.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.
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: added: d9.The actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once the investigation has been completed, a follow-up report will be submitted accordingly.

• Brand Name: 4.5 HEALIX PEEK ANCH.W/OCORD
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle CH-02 400; SZ CH-02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23908920
• Report Number: 1221934-2025-04993
• Device Sequence Number: 18440224
• Product Code: HWC
• UDI-Device Identifier: 10886705007530
• UDI-Public: (01)10886705007530(10)104QSJ(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071481
• 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,Followup
• Report Date (Section B): 12/29/2025

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: 222205
• Device Lot Number: 104QSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 04/23/2026; 04/29/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/28/2026; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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