MAUDE Adverse Event Report: ARTHREX, INC. 3.0 X 14MM VAL SCREW, TI; BONE FIXATION SCREW/PLATE

Model Number	3.0 X 14MM VAL SCREW, TI
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
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 a sales rep.Via email that an ar-8933v-14, low profile va locking screw, 3.0 x 14 mm, ti, was not able to lock into the plate.The surgeon tried to ream and measure again and drilled through val drill guide and all the appropriate instruments were used to insert the screw.On 15/11/2023 - upon further clarification with sales rep, this was discovered during use in a mtp fusion procedure on (b)(6) 2023.The procedure was completed successfully as the surgeon fixed all the other screws except the one seen in the x-ray.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is misuse of the product caused by the surgeon using excessive force and damaging the thread on the device.If the device is damage during use, the device may fail to operate as intended.The complaint allegation was confirmed based on the customer¿s attached picture, which shows the screw with damaged on the thread.

• Brand Name: 3.0 X 14MM VAL SCREW, TI
• 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: emily shafer ; 8009337001
• MDR Report Key: 18292744
• Report Number: 1220246-2023-09306
• Device Sequence Number: 12436554
• Product Code: HWC
• UDI-Device Identifier: 00888867050228
• UDI-Public: 00888867050228
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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 Model Number: 3.0 X 14MM VAL SCREW, TI
• Device Catalogue Number: AR-8933V-14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/03/2025
• 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