FDA Adverse Event
Malfunction
Summary report: N
UNK
MDR report key: 25160629
·
Received May 13, 2026
Report
- Report Number
- 1220246-2026-02832
- Event Type
- Malfunction
- Date Received
- May 13, 2026
- Date of Event
- March 1, 2026
- Report Date
- May 13, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem · 0
ON 23-APR-2026, AN FDA MEDSUN NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE IN (B)(6) 2026, THE TIP OF AN ARTHREX AR-18800-03 DRIVER SHAFT (T6) FRACTURED WITHIN THE HEAD OF A LOCKING SCREW. MULTIPLE ATTEMPTS TO REMOVE THE RETAINED TIP WERE UNSUCCESSFUL. THE SURGEON ELECTED TO LEAVE THE FRAGMENT IN PLACE, NOTING THAT IT APPEARED TO BE COLD-WELDED WITHIN THE SCREW HEAD. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT ARE UNKNOWN. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535594 | UNK | BONE FIXATION SCREW | HWC | ARTHREX, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |