MAUDE Adverse Event Report: ARTHREX, INC. 3.0 X 24MM VAL SCREW, TI, STRL; BONE FIXATION SCREW/PLATE

Model Number	3.0 X 24MM VAL SCREW, TI, STRL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex employee via email that an ar-8952ts-05s gerade low profile-t-platte, an ar-8933v-24s low profile va locking screw, an ar-8933v-26s low profile va locking screw, an ar-8933v-28s low profile va locking screw, an ar-8933v-30s low profile va locking screw, and an ar-8933-30s low pro cortical screw were removed during revision surgery.After the original surgery, a postoperative x-ray showed residual metal fragments.This procedure took place on (b)(6) 2023.No further information has been reported.Additional information requested.
Event or Problem Description
Ar-8952ts-05s gerade low profile-t-plate was not removed, and it remains fixed in the patient.The original procedure was a lisfranc joint dislocation repair.The revision surgery focused on removing the implants; no new parts were implanted.No further information is available.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: 3.0 X 24MM VAL SCREW, TI, STRL
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 17078435
• Report Number: 1220246-2023-06854
• Device Sequence Number: 20401655
• Product Code: HWC
• UDI-Device Identifier: 00888867210318
• UDI-Public: 00888867210318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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 Expiration Date: 04/30/2025
• Device Model Number: 3.0 X 24MM VAL SCREW, TI, STRL
• Device Catalogue Number: AR-8933V-24S
• Device Lot Number: 10986081
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown