inforMED
MalfunctionIOY

SUPPORT ARM 179

Received Nov 24, 2020

Report 8010042-2020-01063 · MDR key 10895986

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 179

Catalog number

6882001

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

EXAMINATION OF THE RETURNED SUPPORT ARM FOUND THAT THE THREAD LOCKER FOR THE LOCKING/UNLOCKING SCREW HAD RELEASED AND THE JOINT COULD FALL APART. THE CAUSE HAS NOT BEEN DETERMINED BUT THE MOST PROBABLE CAUSE WAS FURTHER SCREWING/UNSCREWING OF THE HANDLE AFTER THE STOP OF LOCKING/UNLOCKING CAUSED THE DAMAGE.

Description of Event or Problem

IT WAS REPORTED THAT THE JOINT OF THE SUPPORT ARM WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).