FDA Adverse Event
Injury
Summary report: N
INBONE WRENCH TIB STEM 14
MDR report key: 24372787
·
Received February 17, 2026
Report
- Report Number
- 3010667733-2026-00133
- Event Type
- Injury
- Date Received
- February 17, 2026
- Date of Event
- January 23, 2026
- Report Date
- May 8, 2026
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY INC
- Product Code
- HXC
- UDI-DI
- 00889797030915
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
AS REPORTED: "THE PRODUCT WAS THROWN AWAY IN THE TRASH BECAUSE THE REAMER HEAD PIECE 14MM (200046001) WAS BROKEN OFF ON THE REAMER ROD (200089). THE WRENCH SLID A LITTLE BIT AND BROKE THE MEDIAL MAL OR DISTAL TIBIA AND WE HAD TO FIX THE DISTAL TIBIA WITH ORIF WITH A MEDIAL MAL PLATE. THE PRODUCT WAS THROWN AWAY IN THE TRASH BECAUSE THE REAMER HEAD PIECE 14MM (200046001) WAS BROKEN OFF ON THE REAMER ROD (200089). THE WRENCH SLID A LITTLE BIT AND BROKE THE MEDIAL MAL OR DISTAL TIBIA AND WE HAD TO FIX THE DISTAL TIBIA WITH ORIF WITH A MEDIAL MAL PLATE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499711 | INBONE WRENCH TIB STEM 14 | WRENCH | HXC | WRIGHT MEDICAL TECHNOLOGY INC | 2844221 | 00889797030915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |