FDA Adverse Event
Malfunction
Summary report: N
ROD FOR STRAIGHT CUP HOLDER
MDR report key: 2945946
·
Received January 7, 2013
Report
- Report Number
- 9616680-2013-90015
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 11, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- HSB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS ASSEMBLED AND TIGHTEN WITH A (B)(4) AND A CUP WAS POSITIONED BUT WHEN WE TRIED TO LOOSEN THE HANDLE WE WERE NOT ABLE TO LOOSEN THE HANDLE AGAIN AFTER TIGHTENING. IT SEEMS LIKE IT WAS STUCK IN THE "WRONG POSITION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8451 | ROD FOR STRAIGHT CUP HOLDER | INSTRUMENT | HSB | STRYKER ORTHOPAEDICS CORK | NA | G3090115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |