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

Catalog Number	222205
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
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.Device was used for treatment, not diagnosis.Investigation summary: the product was not returned to j&j medtech orthopaedics, however, a photo was provided for evaluation.Visual inspection of the returned photo found the device was out of its original package.The anchor was found bent at the distal tip.No other anomalies were noted.Manufacturing investigation result for 4.5 healix peek anch.W/ocord: based on the analysis of the provided image, the tip of the anchor exhibits a noticeable bend, which may suggest an incident of mechanical stress.However, the image lacks additional angular perspectives or supplementary details that might aid to identify the root cause of the issue.Such missing information is critical for a comprehensive understanding of the potential causes of this deformation.Furthermore, it is important to note that the image does not show the accompanying tray or the desiccant that is intended to safeguard the product.The absence of these components further limits the ability to assess the full context of the situation and to draw informed conclusions regarding the integrity of the anchor and the overall device.For the assembly of the anchor, the alignment of the anchor is inspected 100% by the operator per procedure.Besides the inspection performed during its manufacturing, there is an additional inspection performed in a sampling plan matter per procedure.Risk assessment and quality systems data analysis: no other complaints regarding impacted lot 8l94849 have been reported.No ncs or capas related to this defect have been opened related to this defect.Root cause description and rationale: the investigation performed showed that the production controls implemented at the non-sterile level, as well as the in-process controls guarantee detection of issues related to a deformed anchor.100% of the product undergoes manufacturing controls for this kind of defect, and additionally every batch passes through quality inspection.Based on the only evidence of the picture without the packaging, root cause cannot be linked to manufacturing.The bounding is limited to reported batch because the received complaint and the risk assessment demonstrate that there is no other quality events related to this type of defect.Conclusion: based on the information presented under this investigation, it is confirmed that manufacturing process has stablished validated procedures which are designed to prevent and detect this defect.Defect cannot be linked to manufacturing since the picture does not show the device packaging.Based on the data reviewed, no capa is deemed necessary, continue to monitor.A review of the batch manufacturing records was conducted on finished lot number 8l94849: and no related non-conformances were identified.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 findings, the potential cause about the reported event is unknown due to the insufficient evidence provided.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 during an unspecified surgical procedure, it was observed that the anchor was deformed and the suture was broken on the device upon opening its package.During in-house engineering evaluation of the photo provided by the customer, it was determined that the anchor was found bent at the distal tip.Another like device was used to complete the procedure with an unspecified delay.There were no adverse consequences to the patient nor surgical delay reported.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: 21413249
• Report Number: 1221934-2025-00602
• Device Sequence Number: 15512676
• Product Code: HWC
• UDI-Device Identifier: 10886705007530
• UDI-Public: (01)10886705007530(10)8L94849(17)250531
• 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): 02/19/2025

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 222205
• Device Lot Number: 8L94849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• 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