inforMED
MalfunctionIOY

SUPPORT ARM 176

Received Sep 2, 2020 · Event occurred Aug 21, 2020

Report 8010042-2020-00586 · MDR key 10481469

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 176

Catalog number

6405976

Product problems

  • Break
  • Break

Patient

Not reported

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

THE BROKEN SUPPORT ARM WAS NOT RETURNED BY THE USER FACILITY. INVESTIGATION WAS BASED ON PICTURE RECEIVED. ACCORDING TO THE PICTURE, THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. THE SUPPORT ARM IS A CASTING AND IT MOST PROBABLY DEVELOPED A CRACK AT AN EARLIER OCCASION EITHER BY OVERLOADING OR IMPACT AND THIS LED TO THE REPORTED BREAKING. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE SUPPORT ARM BROKE. PREVIOUS INVESTIGATIONS OF SIMILAR FAULTS LED TO A REDESIGN AND CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THE SUPPORT ARM ASSOCIATED WITH THIS EVENT HAD BEEN MANUFACTURED BEFORE THIS CHANGE WAS IMPLEMENTED IN PRODUCTION.

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM BROKE AT THE LOWER END. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).