FDA Adverse Event
Malfunction
Summary report: N
APEX
MDR report key: 23381443
·
Received October 24, 2025
Report
- Report Number
- 3007289093-2025-00010
- Event Type
- Malfunction
- Date Received
- October 24, 2025
- Date of Event
- September 23, 2025
- Report Date
- October 24, 2025
- Manufacturer
- EXTREMITY MEDICAL, LLC.
- Product Code
- HXX
- UDI-DI
- 00842078102954
- PMA / PMN Number
- 510K EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT A 2.0 HEX DRIVER SNAPPED IN THE HEAD OF SCREW DURING IMPLANTATION, WAS NOT ABLE TO BE RETRIEVED AND WAS LEFT INSIDE THE PATIENT. NO ADVERSE EVENT REPORTED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1966607 | APEX | SCREWDRIVER | HXX | EXTREMITY MEDICAL, LLC. | 00842078102954 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |