FDA Adverse Event
Injury
Summary report: N
ITOTAL KNEE INSTRUMENTS
MDR report key: 23657858
·
Received November 26, 2025
Report
- Report Number
- 3004153240-2025-00021
- Event Type
- Injury
- Date Received
- November 26, 2025
- Date of Event
- October 28, 2025
- Report Date
- November 26, 2025
- Manufacturer
- RESTOR3D, INC
- Product Code
- JWH
- UDI-DI
- 00810933030599
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
TINE FROM IMPACTOR ADAPTER BROKE OFF DURING SURGERY AND WAS INADVERTENTLY LEFT IN THE PATIENT. PATIENT IS OTHERWISE DOING WELL. INVESTIGATION OF THE FAILURE IS ONGOING.
Description of Event or Problem · 0
TINE FROM IMPACTOR ADAPTOR BROKE OFF DURING SURGERY AND WAS INADVERTENTLY LEFT IN THE PATIENT. THE HOSPITAL NOTICED METAL INCLUDED IN PATIENT'S KNEE POST-OPERTION X-RAY AND SHEDULED AN EXPLORATORY REVISION SURGERY, DURING WHICH THEY LOCATED AND REMOVED THE METAL TINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1947616 | ITOTAL KNEE INSTRUMENTS | ITOTAL REUSABLE INSTRUMENTS | JWH | RESTOR3D, INC | 1080-213 | M190401 | 00810933030599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |