FDA Adverse Event
Malfunction
Summary report: N
TROCHANTERIC NAIL KIT, TI 11X180MM X 125
MDR report key: 2020017
·
Received March 9, 2011
Report
- Report Number
- 9610622-2011-00101
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 17, 2011
- Report Date
- February 18, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS MISSING FROM THE PACKAGE. ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
HEAD OF THEATRE, REPORTS VIA OUR SALES REP, THAT DURING A SURGERY THE PACKAGE WAS OPENED AND THE SET SCREW WAS MISSING. A SET SCREW (B)(4) WAS SEPARATELY AT HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI 11X180MM X 125 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K397188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |