MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE PEEK W/CORD; SCREW, FIXATION, BONE

Catalog Number	222303
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device was returned in used condition.The handle and shaft are in good condition.Upon reviewing the anchor tip it was found that is deformed due to bone friction while insertion.The anchor has a little crack at the distal end.Biological matter can be observed in the center hole of the anchor.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the 4.5 healix advance peek w/cord would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to axial misalignment; as per ifu; insert the distal tip of the peek or br anchor into the bone hole while maintaining the same axial alignment.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 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 the 4.5 healix advance peek w/cord device was defective.During in-house engineering evaluation, it was determined that the anchor tip of the device was deformed due to bone friction while inserting.It was unknown if there was patient involvement.There were no adverse patient consequences nor surgical delay reported.The date of event was unknown but was known to have occurred in 2024.No additional information was provided.

• Brand Name: 4.5 HEALIX ADVANCE PEEK W/CORD
• 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: 20926310
• Report Number: 1221934-2024-04444
• Device Sequence Number: 14719608
• Product Code: HWC
• UDI-Device Identifier: 10886705021390
• UDI-Public: (01)10886705021390(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 222303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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