FDA Adverse Event
Malfunction
Summary report: N
4.0MM CANNULATED SCREW LONG THREAD/46MM
MDR report key: 1082066
·
Received July 23, 2008
Report
- Report Number
- 1719045-2008-00094
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- July 3, 2008
- Report Date
- July 3, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWC
- PMA / PMN Number
- K963192
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE WAS NOT IMPLANTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
INTRAOPERATIVE FILMS REVEALED THE BROKEN FLUTED TIP OF THE 4.0MM CANNULATED SCREW WAS LEFT IN THE PT. UPON REMOVAL OF THE SCREW, THE SURGEON NOTED UNRAVELING OF THE THREADS. AN ALTERNATE SCREW WAS USED TO COMPETE THIS ORIF RIGHT MEDIAL EPICONDYLE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM CANNULATED SCREW LONG THREAD/46MM | CANNULATED SCREWS, LNG THRD | HWC | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | PLATE |