FDA Adverse Event
Death
Summary report: N
THREADED STEINMANN PIN 7/64"
MDR report key: 87163
·
Received April 22, 1997
Report
- Report Number
- 2529767-1997-00005
- Event Type
- Death
- Date Received
- April 22, 1997
- Date of Event
- March 20, 1997
- Report Date
- April 21, 1997
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTY
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT WAS ADMITTED FOR ANOTHER CO'S OF THE DISTAL HUMEROUS. SURGEON USED ANOTHER CO'S CANNULATED SCREW AND CO 7/64" THREADED PIN. A DAY OR TWO LATER, X-RAYS REVEALED THAT BOTH THE SCREW AND THE PIN HAD BROKEN. THE SURGEON REMOVED BOTH ITEMS AND REPLACED THEM. THE 7/64" PIN WAS DISPOSED OF AT THE HOSP. SURGEON WAS NOT USING PIN AS A GUIDE WIRE-HE WAS USING IT AS A FIXATION PIN WITH ANOTHER CO'S SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THREADED STEINMANN PIN 7/64" Implant | 7/64" THREADED PIN | HTY | ZIMMER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Death| O| R |