FDA Adverse Event
Malfunction
Summary report: N
CUSTOM EXTRACTOR AND PIN PULLER
MDR report key: 2003076
·
Received February 8, 2011
Report
- Report Number
- 2249697-2011-00136
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 20, 2011
- Report Date
- January 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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, "BILATERAL TOTAL KNEE. HEADED PINS WOULD NOT FIT INTO THE EXTRACTOR PORTION END OF SLAP HAMMER. THE SURGEON COULD NOT USE THE INSTRUMENT AS DESIGNED. USED RONGEUR TO REMOVE PINS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUSTOM EXTRACTOR AND PIN PULLER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | F5C10025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |