FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN NAIL
MDR report key: 24831595
·
Received April 9, 2026
Report
- Report Number
- 0008031020-2026-00544
- Event Type
- Malfunction
- Date Received
- April 9, 2026
- Date of Event
- March 13, 2026
- Report Date
- April 9, 2026
- Manufacturer
- STRYKER GMBH
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
AS REPORTED: ¿DURING A T2 PHN SURGERY, THE SURGEON DRILLED ALL PROXIMAL SCREWS INCORRECTLY WHEN USING THE T2 PHN TARGETING DEVICE. THE BONDED CONNECTION BETWEEN THE METALLIC AND CARBON PARTS APPEARS TO BE LOOSE. CRACKS ARE VISIBLY PRESENT AT THE JOINT/INTERFACE. 30 MIN SURGICAL DELAY.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93902 | UNKNOWN NAIL | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | STRYKER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |