FDA Adverse Event
Malfunction
Summary report: N
TROCHANTERIC NAIL KIT, TI 11X180MM X 130
MDR report key: 2441911
·
Received January 31, 2012
Report
- Report Number
- 9610622-2012-00062
- Event Type
- Malfunction
- Date Received
- January 31, 2012
- Date of Event
- January 13, 2012
- Report Date
- January 17, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED TO OUR SALES REP THAT WHILE OBSERVING SURGERY THE INVOLVED SURGEON REPORTED THAT HE SET SCREW COULD NOT BE INCORPORATED INTO THE NAIL. THE SURGEON TRIED ANOTHER LOCKING SCREW AND IT WORKED. THERE WAS A DELAY OF 10 MIN. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI 11X180MM X 130 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K21605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |