FDA Adverse Event
Malfunction
Summary report: N
REAMER SHAFT, AO FITTING ?8,0X448 MM
MDR report key: 2388818
·
Received December 7, 2011
Report
- Report Number
- 9610622-2011-00606
- Event Type
- Malfunction
- Date Received
- December 7, 2011
- Date of Event
- October 27, 2011
- Report Date
- November 18, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ALSO ASSOCIATED WITH THIS EVENT IS CATALOG NO. 1806-0085S, LOT # K461703, GUIDE WIRE, BALL-TIPPED, STERILE 3X1000 MM.
Description of Event or Problem · 1
RESIDENT AT THE HOSPITAL, REPORTED THAT DURING A SURGERY, THE REAMER GOT BLOCKED IN THE GUIDE. THE SURGEON USED ANOTHER DEVICE TO FINISH THE SURGERY WITHOUT DELAY. NO ADVERSE CONSEQUENCES WERE REPORTED FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REAMER SHAFT, AO FITTING ?8,0X448 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K624488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |