FDA Adverse Event
Malfunction
Summary report: N
3.2MM THREE-FLUTED DRILL BIT
MDR report key: 1051178
·
Received May 22, 2008
Report
- Report Number
- 2520274-2008-00043
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- May 2, 2008
- Report Date
- May 6, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND NOT IMPLANTED. SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURING SITE OR DATE WITHOUT THE LOT NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
DURING A TIBIAL NAILING, THE DRILL BIT BROKE OFF AFTER COMING INTO CONTACT WITH THE NAIL. THE SURGEON WAS NOT ABLE TO RETRIEVE THE TIP OF THE DRILL BIT AND LEFT IT LODGED IN THE BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.2MM THREE-FLUTED DRILL BIT | THREE-FLUTED DRILL BIT | HTW | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | TIBIAL NAIL |