FDA Adverse Event Malfunction Summary report: N

CARPALFIX

MDR report key: 19973044 · Received August 13, 2024

Report

Report Number
3007289093-2024-00011
Event Type
Malfunction
Date Received
August 13, 2024
Date of Event
June 20, 2024
Report Date
August 13, 2024
Manufacturer
EXTREMITY MEDICAL, LLC.
Product Code
HWC
PMA / PMN Number
K121349
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE CARPALFIX 2.0 HEX DRIVER INRAOPERATIVELY. THE COMPLAINANT INDICATED THAT THE SURGEON PLANNED TO PUT TWO CARPALFIX CONSTRUCTS IN THE PATIENT (A POST IN HAMMATE, A SCREW IN 4TH AND POST IN HAMMATE, AND A SCREW IN 5TH). SURGEON PLACED THE K-WIRE, TEMPLATED, DRILLED, CONICAL REAMED AND PLACED THE POST. HE PLACED THE K-WIRE IN THE SCREW DRIVER AND ROTATIONS BACK AND FORTH TO DETERMINE THE OPTIMUM LAG SCREW POSITION. HE CHOSE THE DESIRED POSITION, TRIED TO DISCONNECT SCREWDRIVER OFF BUT IT WAS COMPLETELY STUCK. HE TRIED A GENTLE TAP ON THE SCREWDRIVER, USING BOTH HANDLES, NIBBLERS GRABBING TEH SCREWDRIVER AND TAPPING THE NIBBLERS IN UPWARD DIRECTION WHILST STABILIZING THE POST IN A COUNTER DIRECTION. THESE DID NOT WORK. HE THEN TRIED A GENTLE WOBBLE (WHICH HE WAS TRYING TO AVOID SO HE DIDN'T LOOSEN THE PURCHASE OF THE POST IN THE BONE.) HE EVENTUALLY HAD TO BASH IT OUT WITH A LOT OF FORCE. THE POST PULLED OUT OF THE BONE AND HE HAD TO USE THE MEDARTUS HUB CAP INSTEAD. THE SCRUB NURSE USED NEEDLE HOLDER TO REMOVE THE POST FROM SCREWDRIVER ONCE OUT THE PATIENT, WHICH CAME OUT EASIER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1683445 CARPALFIX BONE SCREW HWC EXTREMITY MEDICAL, LLC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown