FDA Adverse Event
Malfunction
Summary report: N
IM REAMER, MOD. TRINKLE FITTING 11, 0X480MM
MDR report key: 1082450
·
Received July 22, 2008
Report
- Report Number
- 9610622-2008-00128
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 29, 2008
- Report Date
- July 8, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HTO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, SURGEON INSERTED A 3X800 BALL TIP GUIDE WIRE. SHE STARTED REAMING. SHE GOT TO THE 11 MM REAMER, REAMED THE CANAL. AS SHE WAS TRYING TO TAKE THE REAMER OUT, THERE WAS RESISTANCE. ONCE THE REAMER WAS REMOVED FROM THE PT, THE TOP OF THE REAMER AND BOTTOM HAD STARTED TO UNCOIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IM REAMER, MOD. TRINKLE FITTING 11, 0X480MM | INSTRUMENT | HTO | STRYKER OSTEOSYNTHESIS KIEL | NA | K502605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |