FDA Adverse Event
Injury
Summary report: N
APERFIX FEMORAL IMPLANT WITH INSERTER
MDR report key: 5305130
·
Received December 16, 2015
Report
- Report Number
- 3006108336-2015-00006
- Event Type
- Injury
- Date Received
- December 16, 2015
- Date of Event
- November 17, 2015
- Report Date
- December 16, 2015
- Manufacturer
- CAYENNE MEDICAL, INC.
- Product Code
- HWC
- PMA / PMN Number
- K082612
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO CAYENNE MEDICAL THAT DURING IMPLANTATION OF THE TIBIAL IMPLANT, THE GUIDEWIRE BROKE AND A BROKEN PIECE WAS LEFT IN THE PATIENT. THEREFORE, A C-ARM WAS BROUGHT IN TO THE OPERATING ROOM TO FIND THE PIECE OF THE BROKEN TIBIAL GUIDEWIRE. WHILE X-RAYING FOR THE BROKEN PIECE OF GUIDEWIRE, THE SURGEON NOTICED THAT THE HEAD OF THE FEMORAL SCREW (PART OF THE FEMORAL IMPLANT) WAS ALSO BROKEN. THE SURGEON WAS ABLE TO LOCATE THE BROKEN PIECE OF GUIDEWIRE BY REMOVING THE TIBIAL IMPLANT AND THEREFORE, IT WAS REMOVED FROM THE PATIENT'S KNEE. THE SURGEON REPORTED THAT HE/SHE WAS UNABLE TO LOCATE THE BROKEN PIECE OF THE FEMORAL SCREW; THEREFORE, HE/SHE DECIDED TO LEAVE THE BROKEN PIECE IN THE PATIENT'S KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831670 | APERFIX FEMORAL IMPLANT WITH INSERTER | BONE SCREW | HWC | CAYENNE MEDICAL, INC. | CM-2911 | 46320-4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |