FDA Adverse Event
Injury
Summary report: N
NAIL ADAPTER
MDR report key: 1063422
·
Received June 19, 2008
Report
- Report Number
- 9610622-2008-00091
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- May 30, 2008
- Report Date
- May 30, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE SURGEON, REPORTED TO SALES MGR OF OSTEOSYNTHESIS THAT HE DISCOVERED THAT THE LAG SCREWS MISSED THE NAIL DURING POST-OPERATIVE CHECK. THE SURGEON FURTHER REPORTED THAT THE PT HAD TO BE RE-OPERATED 5 DAYS AFTER THE INITIAL SURGERY. SURGEON ALSO REPORTED THAT THE PROXIMAL SCREWS WERE REMOVED USING THE FREEHAND TECHNIQUE AND PLACED AGAIN VIA THE FREEHAND TECHNIQUE. THE SURGEON STATED THAT HE HAD SOME DIFFICULTIES WITH ASSEMBLING THE TARGET DEVICE DURING THE FIRST SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAIL ADAPTER | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KP222447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |