FDA Adverse Event
Malfunction
Summary report: N
DYNANAIL TTC FUSION NAIL
MDR report key: 14632438
·
Received June 7, 2022
Report
- Report Number
- MW5110175
- Event Type
- Malfunction
- Date Received
- June 7, 2022
- Report Date
- June 3, 2022
- Manufacturer
- MEDSHAPE, INC.
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
NAIL USED DURING SURGERY WAS DEFECTIVE. NAIL WAS IMPLANTED INTO THE PATIENT, AFTER REALIZING IT WAS DEFECTIVE THE NAIL WAS EXPLANTED AND A NEW NAIL WAS IMPLANTED. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324721 | DYNANAIL TTC FUSION NAIL | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | MEDSHAPE, INC. | 1200-01-1022 | D0055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |