FDA Adverse Event
Malfunction
Summary report: N
RETROGRADE DRL 10MM
MDR report key: 6359497
·
Received February 25, 2017
Report
- Report Number
- 1643264-2017-00114
- Event Type
- Malfunction
- Date Received
- February 25, 2017
- Date of Event
- February 15, 2017
- Report Date
- April 5, 2017
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- GFG
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VISUAL ASSESSMENT OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT OF BREAKAGE. THE DRILL HEAD HAS SPLIT IN TWO PIECES AND HAS COME FREE FROM THE DRILL SHAFT. THE BREAK IS A CLEAN SHEAR WITH A SLIGHT TWIST. THE ACTUATOR WIRE IS SPIRALED IN THE FORWARD DRILLING POSITION.
Description of Event or Problem · 1
IT WAS REPORTED THE RETROGRADE DRILL (10MM) BROKE DURING A PROCEDURE. ALL PIECES REMOVED FROM PATIENT. A BACK UP DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141702 | RETROGRADE DRL 10MM | BIT, SURGICAL | GFG | SMITH & NEPHEW, INC. | G10378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |