FDA Adverse Event
Malfunction
Summary report: N
PERFORATOR DRIVER WITH HUDSON END
MDR report key: 4171585
·
Received October 14, 2014
Report
- Report Number
- 1045834-2014-14404
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Report Date
- June 21, 2013
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBE
- PMA / PMN Number
- PK965080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
CUSTOMER REPORTED THE DEVICE IS STUCK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650163 | PERFORATOR DRIVER WITH HUDSON END | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |