FDA Adverse Event
Malfunction
Summary report: N
MRH REAM DPTH STP:80MM FEMUR
MDR report key: 2020481
·
Received February 16, 2011
Report
- Report Number
- 9610726-2011-00039
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 2, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- HTJ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
NURSE, HEAD OF THEATRE REPORTS VIA OUR SALES REP, THAT THE DEPTH GAUGE BROKE DURING SURGERY AT THE CLAMP WHICH IS INTENDED FOR FASTENING. THE SURGERY WAS FINISHED BY HOLDING THE DEPTH GAUGE MANUALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRH REAM DPTH STP:80MM FEMUR | INSTRUMENT | HTJ | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |