VAL SCREW, TI, 2.0 X 14MM
Report
- Report Number
- 1220246-2025-00885
- Event Type
- Malfunction
- Date Received
- March 12, 2025
- Date of Event
- February 21, 2025
- Report Date
- September 10, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRS
- UDI-DI
- 00888867311718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 501
Narratives
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.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION: B5, D1, D4, H3, H6.
ON 2/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO 2.0 MM SCREW HEADS SNAPPED OFF. THE FIRST SCREW HEAD BROKE OFF DURING INSERTION AND THE SECOND ONE BROKE WHEN IT WAS BEING REMOVED, IN EXCHANGE FOR A SHORTER SCREW. THE FRAGMENTS WERE REMOVED. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE PROCEDURE ON (B)(6) 2025
ADDITIONAL INFORMATION RECEIVED ON 3/6/2025: THE PART NUMBER FOR THE SCREWS ARE AR-18720V-14 VAL SCREW AND AR-18720-12 CORTICAL SCREW. THE BODY OF BOTH SCREWS REMAINS IN THE PATIENT. THE CASE WAS COMPLETED USING AN AR-18720V-14 VAL SCREW AND AN AR-18720-12 CORTICAL SCREW. THE CASE WAS DELAYED FOR ABOUT FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1399447 | VAL SCREW, TI, 2.0 X 14MM | BONE FIXATION SCREW/PLATE | HRS | ARTHREX, INC. | VAL SCREW, TI, 2.0 X 14MM | UNK | 00888867311718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |