FDA Adverse Event
Malfunction
Summary report: N
611 ANKLE FUSION NAIL DRILL
MDR report key: 5049630
·
Received September 2, 2015
Report
- Report Number
- 3000931034-2015-00133
- Event Type
- Malfunction
- Date Received
- September 2, 2015
- Date of Event
- August 4, 2015
- Report Date
- August 4, 2015
- Manufacturer
- TORNIER S.A.S.
- Product Code
- HTW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Additional Manufacturer Narrative · 1
THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Description of Event or Problem · 1
DURING THE DISTAL LOCKING OF THE NAIL (PROXIMAL LOCKING AND COMPRESSION DONE), THE DRILL OF THE MOST DISTAL HOLE MET THE NAIL IN SITU. THE SURGEON PASSED THROUGH THE NAIL BUT THE DRILL BROKE. THE TIP OF THE DRILL REMAINS IN THE NAIL HOLE AND ABOUT 2 CM STAYED INTO THE PATIENT.
Description of Event or Problem · 1
DURING THE DISTAL LOCKING OF THE NAIL (PROXIMAL LOCKING AND COMPRESSION DONE), THE DRILL OF THE MOST DISTAL HOLE MET THE NAIL IN SITU. THE SURGEON PASSED THROUGH THE NAIL BUT THE DRILL BROKE. THE TIP OF THE DRILL REMAINS IN THE NAIL HOLE AND ABOUT 2 CM STAYED INTO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582857 | 611 ANKLE FUSION NAIL DRILL | DRILL | HTW | TORNIER S.A.S. | 12E794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |