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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (277l414), and no non-conformances related to the reported complaint condition were identified.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device 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 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 following an unknown surgery using the 4.5 healix peek anch.W/ocord device, the patient returned to the outpatient clinic with poor postoperative wound healing.It was reported that during the operation on (b)(6) 2024, due to muscle strength imbalance, the tendon was dissected from the medial end and transferred to balance muscle strength, anchoring the muscle to the bone using anchors.Postoperative muscle strength balance, and foot varus improvement were reported.It was reported that the implant wound healed well postoperatively without adverse events.It was further reported that on (b)(6) 2024, the patient returned to the outpatient clinic with poor postoperative wound healing and on (b)(6) 2025, the patient was readmitted for debridement and drainage with poor postoperative wound healing.The patient is currently under treatment.No additional information was provided.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: correction: b5: event date: additional information confirmed the event date to be 31-dec-2024.Additional information: b5: the patient has been discharged smoothly, and no subsequent adverse event report was received.

• 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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 21512786
• Report Number: 1221934-2025-00838
• Device Sequence Number: 7962414
• Product Code: HWC
• UDI-Device Identifier: 10886705007530
• UDI-Public: (01)10886705007530(10)277L414(17)270131
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 222205
• Device Lot Number: 277L414
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male