FDA Adverse Event
Malfunction
Summary report: N
ONE STEP CONICAL REAMER 15.5X350 MM
MDR report key: 1981641
·
Received January 12, 2011
Report
- Report Number
- 9610622-2011-00012
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 22, 2010
- Report Date
- December 22, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAME PATIENT EVENT AS MDR 9610622-2011-00013.
Description of Event or Problem · 1
DURING THE G3 SURGERY, WHEN THE ONE STEP CONICAL REAMER WAS USED, THE SURGEON WAS NOT ABLE TO PASS THE ONE STEP CONICAL REAMER THROUGH THE CONICAL REAMER SLEEVE. THEREFORE, THE SURGEON CHANGED THE PROCEDURE AND THE SURGERY WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE STEP CONICAL REAMER 15.5X350 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |