FDA Adverse Event
Malfunction
Summary report: N
PLATE LOCKING SCREW 14MM
MDR report key: 2772245
·
Received October 2, 2012
Report
- Report Number
- 1651501-2012-00045
- Event Type
- Malfunction
- Date Received
- October 2, 2012
- Date of Event
- September 7, 2012
- Report Date
- October 2, 2012
- Manufacturer
- ASCENSION ORTHOPEDICS
- Product Code
- HRS
- PMA / PMN Number
- K032634
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
THE RPTR NOTED: "DURING METATARSAL PHALANGEAL ARTHRODESIS SURGERY; AS THE SURGEON IMPLANTED THE LOCKING SCREW, IT HAD SHARDS OF METAL BREAKING OFF THE SCREW. THE DOCTOR REMOVED THE METAL SHARDS FROM THE PT, REMOVED THE SCREW AND THEN IMPLANTED A 14MM STANDARD SCREW. THE SURGEON REPORTED HE DID NOT USE THE DRILL GUIDE WITH THE LOCKING SCREW. THE LOCKING SCREW WAS DISCARDED. THERE WAS NO PT INJURY. THE SURGERY WAS DELAYED BY 2 TO 3 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLATE LOCKING SCREW 14MM | RADFX | HRS | ASCENSION ORTHOPEDICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |