FDA Adverse Event
Malfunction
Summary report: N
GAMMA NAIL TARGET DEVICE
MDR report key: 2132428
·
Received June 14, 2011
Report
- Report Number
- 9610622-2011-00255
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 30, 2011
- Report Date
- May 30, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 THE SLEEVE WOULD NOT LOCK ON TO 125 OR 130 DEGREES. THE SURGEON LINED UP THE DOTS AND HAD TO HOLD IT IN PLACE TO CONTINUE THE SURGERY BECAUSE THE TARGET DEVICE WOULD NOT LOCK INTO PLACE. WHEN THE REP GOT THE TARGET BACK TO THE OFFICE, HE NOTICED THAT THE RIDGES ON THE BOTTOM LOOKED LIKE THEY WERE CHIPPED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GAMMA NAIL TARGET DEVICE | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KME902813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR |