FDA Adverse Event
Malfunction
Summary report: N
HEX DRIVER 2.5MM AO; HEX DRIVER 3.5 AO
MDR report key: 7105706
·
Received December 11, 2017
Report
- Report Number
- 2031009-2017-00006
- Event Type
- Malfunction
- Date Received
- December 11, 2017
- Date of Event
- February 15, 2017
- Report Date
- February 14, 2017
- Manufacturer
- TRIMED INC.
- Product Code
- HWR
- UDI-DI
- 00842188112621
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
A HXDRIVR-2.5 AO AND HXDRIVR-3.5 AO WERE FLASHED IN AN AUTOCLAVE IN CENTRAL STERILE DUE TO A HOLE IN THE STERILE WRAPPING. THE SCRUB TECH NOTICED UPON OPENING THE TRAY FOR POST-STERILIZATION INSPECTION, THAT BOTH DRIVERS HAD EPOXY COMING OFF AFTER STERILIZATION. THE TRAY WAS A LOANER TRAY, THE SURGEON STATED THAT THIS INCIDENT WAS NOT AN ISSUE FOR THEM AS THE DRIVERS WERE NOT USED IN SURGERY AND THEY FELT THAT THIS INCIDENT DID NOT NEGATIVELY AFFECT THE PATIENT'S HEALTH OR DELAY SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 886415 | HEX DRIVER 2.5MM AO; HEX DRIVER 3.5 AO | HEX DRIVERS | HWR | TRIMED INC. | HXDRIVR-2.5 AO; HXDRIVR3.5 AO | 92238; 91857 | 00842188112621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |