FDA Adverse Event
Malfunction
Summary report: N
ZIMMER M/L TAPER RASP
MDR report key: 3546911
·
Received October 23, 2013
Report
- Report Number
- 1822565-2013-01530
- Event Type
- Malfunction
- Date Received
- October 23, 2013
- Date of Event
- September 23, 2013
- Report Date
- September 25, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT WHILE REAMING, THE POST OF THE RASP BROKE OFF LEAVING THE RASP LODGED IN THE PATIENT. FURTHER BONE NEEDED TO BE REMOVED BY THE SURGEON TO ACCESS THE REMOVAL HOLD ON THE RASP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 544430 | ZIMMER M/L TAPER RASP | HTR | ZIMMER, INC. | 60344962 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |