FDA Adverse Event
Malfunction
Summary report: N
4.2MM RADIOLUCENT DRILL BIT
MDR report key: 12548556
·
Received September 29, 2021
Report
- Report Number
- 3015967359-2021-02080
- Event Type
- Malfunction
- Date Received
- September 29, 2021
- Date of Event
- September 3, 2021
- Report Date
- November 22, 2021
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- GFG
- UDI-DI
- 04546540348593
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A T2 SCN SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE OF NAIL, THE DRILL BIT BROKE. NO FURTHER INFORMATION WAS AVAILABLE.
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED BY CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A T2 SCN SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE OF NAIL, THE DRILL BIT BROKE. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1444807 | 4.2MM RADIOLUCENT DRILL BIT | BIT, SURGICAL | GFG | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | 4200355042 | 21168027 | 04546540348593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |