FDA Adverse Event
Malfunction
Summary report: N
#7 4:1 CUTTING BLOCK
MDR report key: 1865107
·
Received October 5, 2010
Report
- Report Number
- 2249697-2010-01309
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Date of Event
- August 25, 2010
- Report Date
- September 14, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE 4:1 CUTTING BLOCK WAS PLACED ON FEMUR, WHEN TIME TO REMOVE THE PEG ON BACK OF CUTTING BLOCK FELL OFF AND STAYED IN FEMUR. USED PLIERS TO PULL OUT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | #7 4:1 CUTTING BLOCK | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | SBYM04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |