FDA Adverse Event
Malfunction
Summary report: N
SMALL BONE PHANTOM INTRAMEDULLARY NAIL SYSTEM
MDR report key: 11749836
·
Received April 29, 2021
Report
- Report Number
- 3008650117-2021-00087
- Event Type
- Malfunction
- Date Received
- April 29, 2021
- Date of Event
- April 26, 2021
- Report Date
- April 29, 2021
- Manufacturer
- PARAGON 28, INC
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
AS OF (B)(6) 2021, THE INVESTIGATION IS STILL BEING CONDUCTED.
Additional Manufacturer Narrative · 0
BASED ON INFORMATION PROVIDED, THIS FAILURE OCCURRED UNDER PREVIOUS CIRCUMSTANCES. WE CANNOT ELIMINATE OR ASSIGN USER ERROR BASED ON THE LIMITED INFORMATION. BASED ON HISTORICAL COMPARABLE COMPLAINTS, THIS FAILURE OF EXCESSIVE TORQUE WAS ATTRIBUTED TO USER ERROR AND IS NOT REPORTABLE.
Additional Manufacturer Narrative · 1
INITIAL INFORMATION RECEIVED. FURTHER INFORMATION IS EXPECTED TO BE OBTAINED; A SUBSEQUENT REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem · 1
BROKEN INSTRUMENT. TIMING OF EVENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647183 | SMALL BONE PHANTOM INTRAMEDULLARY NAIL SYSTEM | LAPIDUS NAIL TORQUE INDICATING DRIVER, T10 | HXX | PARAGON 28, INC | P30-100-TORQ | MT32147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |