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