SERVO-I
Received May 25, 2021 · Event occurred Apr 30, 2021
Report 8010042-2021-01176 · MDR key 11876701
Device
Product problems
- Break
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PARTS WERE RETURNED. INVESTIGATION WAS BASED ON PICTURE RECEIVED. ACCORDING TO THE PICTURE, THE SUPPORT ARM BROKE AT THE JOINT SECOND 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. 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 COMPLAINT 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).