MAUDE Adverse Event Report: ARTHREX, INC. VAL SCREW, TI, 1.6 X 13MM; BONE FIXATION PLATE

Model Number	VAL SCREW, TI, 1.6 X 13MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-18716-13, an ar-18716-12, cortical low-profile screws, and an ar-18716v-13 val screw broke during insertion.All three screws head broke off and were retrieved; the body of the screws remain implanted in the patient.This was discovered during a finger fracture procedure on (b)(6) 2023.
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.
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 description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed misuse due to misaligned insertion; or prying/leveraging the screw during insertion.

• Brand Name: VAL SCREW, TI, 1.6 X 13MM
• Common Device Name: BONE FIXATION 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: 17662620
• Report Number: 1220246-2023-07736
• Device Sequence Number: 15014421
• Product Code: HRS
• UDI-Device Identifier: 00888867313705
• UDI-Public: 00888867313705
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: VAL SCREW, TI, 1.6 X 13MM
• Device Catalogue Number: AR-18716V-13
• Device Lot Number: 2684812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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