FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW, FULLY THREADED 5X40MM
MDR report key: 1160547
·
Received September 10, 2008
Report
- Report Number
- 9610622-2008-00166
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- August 17, 2008
- Report Date
- August 20, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWC
- PMA / PMN Number
- K003018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "GAMMA3 TROCHANTERIC NAIL PROCEDURE. DURING PROCEDURE, WHEN SURGEON CAME TO DISTALLY LOCK THE NAIL, HE DRILLED WITH APPROPRIATE DRILL MEASURED FOR A 40MM SCREW. THE 40MM SCREW WAS OPENED BUT COULD GET IT TO ADVANCE. WHEN SURGEON WENT TO INSERT SCREW, IT WOULD NOT ADVANCE. SURGEON CHECKED THE SCREW AND THEN TRIED A 2ND TIME, BUT SCREW WOULD NOT GO IN. ANOTHER 40MM SCREW WAS OPENED AND WENT IN SUCCESSFULLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW, FULLY THREADED 5X40MM | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS KIEL | NA | K914518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |