MAUDE Adverse Event Report: DEPUY MITEK LLC US PROFILE INTSCR 8X25MM *EA; SCREW, FIXATION, BONE

Catalog Number	230425
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that 2x profile intscr 8x25mm packages listed the production date of the device as (2022), stated a 3-year expiration date, and stated a use-by date of 2027-08-31.The physician felt there was a discrepancy.The physician felt that either the expiration date is incorrect (it should be 5 years), or the screws are already expired.It was reported that the devices were not used in a surgical procedure.There were no adverse consequences to the patient.The exact date of the event was not reported; however, it was reported that the event occurred in 2025.No additional information could be provided.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: investigation summary: the product was not returned to depuy synthes; however photos were provided for evaluation.Visual inspection of the returned photos found that there is a different expiration date between the outer product label and local language label.Manufacturing investigation results for profile intscr 8x25mm *ea: the expiration date is 5 years.The label with the discrepancy is not placed at the manufacturing site.It must be placed at a relabeling center, either at the edc or the loc in russia.The overall complaint was confirmed as the observed condition of the profile intscr 8x25mm *ea would have contributed to the complained device issue.Based on the findings, the potential cause is undetermined.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 depuy synthes 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.

• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23583193
• Report Number: 1221934-2025-04446
• Device Sequence Number: 18467918
• Product Code: HWC
• UDI-Device Identifier: 10886705010479
• UDI-Public: (01)10886705010479(10)9L69821(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K961234
• 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,Followup

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: 230425
• Device Lot Number: 9L69821
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown