MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN RC 5.0 W/OCORD W/NDLS; SCREW, FIXATION, BONE

Catalog Number	222991
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
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.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.H11: additional narrative: 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 no observations pertaining to the nature of the reported event or any other anomaly.The overall complaint was not confirmed as the observed condition of the fastin rc 5.0 w/ocord w/ndls would have not contributed to the complained device issue.Based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established 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.Device history record review: a device history review was performed and no non-conformances were identified related to the reported condition.
Event or Problem Description
It was reported that during an unspecified surgical procedure, the anchor on the fastin rc 5.0 w/ocord w/ndls device was found to be broken.According to the reporter, while the surgeon was inserting the fastin anchor, strain was lost when passing through the tissue ¿(m.R.)¿, causing the anchor to become misaligned or loosened from the tip of the handle.The surgeon attempted to reposition the anchor back in the handle, but when trying to pass it through the tissue again, the tension in the threads was lost.The surgeon indicated that the anchor did not grip properly, and when removing the handle from the anchor, the entire suture came out with it, leaving the anchor in place while the threads were completely cut.It was reported that there were no delays to the surgical procedure as a spare device was available to complete the surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.

• Brand Name: FASTIN RC 5.0 W/OCORD W/NDLS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 22523357
• Report Number: 1221934-2025-02619
• Device Sequence Number: 18282858
• Product Code: HWC
• UDI-Device Identifier: 10886705008698
• UDI-Public: (01)10886705008698(10)263L179(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K060664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 222991
• Device Lot Number: 263L179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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: Male