FDA Adverse Event
Malfunction
Summary report: N
AUTOFIX STAINLESS STEEL
MDR report key: 4317380
·
Received November 21, 2014
Report
- Report Number
- 9680024-2014-00001
- Event Type
- Malfunction
- Date Received
- November 21, 2014
- Date of Event
- October 10, 2014
- Report Date
- November 5, 2014
- Manufacturer
- SMALL BONE INNOVATIONS INTERNATIONAL, S. A. S.
- Product Code
- HWC
- PMA / PMN Number
- K052576
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MATERIAL MANAGER AT THE SURGICAL FACILITY CONFIRMED THAT THE HEAD OF THE SCREW BROKE OFF DURING IMPLANTATION. THE BOTTOM THREADING AND SHAFT REMAIN IN THE PT, WHILE THE BROKEN HEAD WAS DISCARDED AT THE FACILITY. THERE WAS NO CONSEQUENCE TO THE PT REPORTED AND THE SURGERY WAS STATED TO HAVE BEEN COMPLETED SUCCESSFULLY.
Description of Event or Problem · 1
AN AUTOFIX CANNULATED COMPRESSION SCREW BROKE DURING IMPLANTATION. PART OF THE BROKEN CANNULATED COMPRESSION SCREW REMAINS IN THE PT, WHILE THE PIECE THAT BROKE OFF WAS DISPOSED BY THE FACILITY. THE SURGERY WAS REPORTED SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758126 | AUTOFIX STAINLESS STEEL | CANNULATED COMPRESSION SCREW | HWC | SMALL BONE INNOVATIONS INTERNATIONAL, S. A. S. | 141-2020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |