HOLDER LEG
Received May 16, 2017 · Event occurred Apr 3, 2017
Report 1219602-2017-00495 · MDR key 6571146
Device
Generic name
Restraint, Patient, Conductive
Manufacturer
Smith & Nephew, Inc.Catalog number
012310
Lot number
EPO
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ONE LEG HOLDER WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE SHOWS IT IS WELL WORN. THERE IS DAMAGE TO THE PADS AND THEIR ASSEMBLIES. THE POSITIONING LOCKS THREADS ARE STRIPPED. THE PLATING IS COMING OFF OF THE LATERAL PAD LOCK ASSEMBLY. A MACHINE SCREW HAS BEEN PLACED IN THE LATERAL PAD LOCK ASSEMBLY. THE DEVICE IS IN NEED OF COMPLETE REFURBISHMENT AND LIKELY DID AT THE TIME OF THIS INCIDENT. WE RECOMMEND THAT ALL RE-USABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR/DAMAGE AND REPLACED OR REPAIRED AS NECESSARY. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE THE PIN WILL NOT KEEP THE LEG LOCKED. A BACK UP DEVICE OF THE SAME KIND WAS AVAILABLE TO CONTINUE THE PROCEDURE. NO PATIENT HARM WAS REPORTED. THE LEG WAS ABLE TO SHIFT/ROTATE BUT IT IS UNKNOWN IF TRACTION WAS LOST.