FDA Adverse Event
Malfunction
Summary report: N
PLATE CUTTER
MDR report key: 2132456
·
Received June 14, 2011
Report
- Report Number
- 8031020-2011-00137
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 27, 2011
- Report Date
- May 27, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, AFTER A 3.0 X 450MM T2 KIDS FLEX NAIL, STAINLESS STEEL WAS IMPLANTED IN THE PATIENT, THE SURGEON WENT ABOUT TO CUT THE EXCESS OF THE NAIL LENGTH OUTSIDE THE BONE. IN DOING SO, WHEN HE PLACED THE FLEX NAIL BETWEEN THE BLADES AND CLOSED THEM, ONE OF THE BLADES CHIPPED AWAY AND INTO THE PATIENT'S BODY. LUCKILY, DR (B)(6) WAS ABLE TO RETRIEVE THE BROKEN PIECE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLATE CUTTER | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | N20228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Other |