FDA Adverse Event
Malfunction
Summary report: N
BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4M
MDR report key: 1915423
·
Received November 5, 2010
Report
- Report Number
- 8010177-2010-00421
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 15, 2010
- Report Date
- October 15, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K022185
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
SURGEON WAS USING A 1.2 X 5MM SD SCREW TO FIX A PLATE (B)(4) USING A RATCHET HANDLE (B)(4) SCREWDRIVER, AND THE HEAD OF THE SCREW SHEARED OFF. ANOTHER ITEM WAS USED INSTEAD AND CASE WAS COMPLETED AS ORIGINALLY PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4M | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |