FDA Adverse Event
Malfunction
Summary report: N
HOLLOW DRILL BIT Ø10 F/MULTILOC HUM NAIL
MDR report key: 3123137
·
Received May 21, 2013
Report
- Report Number
- 8030965-2013-02315
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- February 22, 2011
- Report Date
- March 3, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- GFG
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
BLOCKED HOLLOW DRILL WITH LEADING K WIRE, DURING DRILLING THE DRILL STOPPED AND WOULD NOT PERFORM FURTHER DRILLING. PROCEDURE WAS PERFORMED WITH A HOLLOW REAMER FROM ANOTHER SET. THIS IS 1 OF 2 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224999 | HOLLOW DRILL BIT Ø10 F/MULTILOC HUM NAIL | GFG | SYNTHES GMBH | 2662664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |