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	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.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.H11 additional narrative: e1: the reporter¿s complete facility address was not provided.The product has not returned to j&j medtech orthopaedics, however a photo was provided for review.Visual inspection of the returned photo found that the anchor was still attached to the inserter and broken at the distal end, the anchor had foreign matter, presumably biological matter.No other anomalies were noted.The overall complaint was confirmed as the observed condition of 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 or drill to less than the specified depth, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.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 complaint condition.As part of j&j medtech orthopaedics 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 a rotator cuff repair procedure, the the 4.5 healix peek anch.W/ocord device anchor was broken off, removed all the broken parts.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information was provided.

• 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): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 22507703
• Report Number: 1221934-2025-02578
• Device Sequence Number: 13077632
• Product Code: HWC
• UDI-Device Identifier: 10886705007530
• UDI-Public: (01)10886705007530(10)250L697(17)261031
• 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
• Report Date (Section B): 07/15/2025

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: 250L697
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown