inforMED
MalfunctionCCX

ACUFEX ACCESS LATERAL TRACTION BOOM

Received Jun 12, 2020 · Event occurred May 14, 2020

Report 1643264-2020-00339 · MDR key 10151139

Device

Generic name

Support, Patient Position

Model number

72205103

Catalog number

72205103

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Description of Event or Problem

IT WAS REPORTED THAT WHILE TESTING THE ACUFEX ACCESS LATERAL TRACTION BOOM IS DOWN, THE BLUE RING WON'T LOCK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

H10 H3,H6: THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION REVEALED NO ISSUES. A FUNCTIONAL EVALUATION FOUND THAT THE BLUE RING WOULDN'T LOCK DUE TO A POLISHING STONE FROM MANUFACTURING BEING STUCK IN THE QUICK CONNECT LOCKING CHANNEL. THE COMPLAINT WAS CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE AN INADVERTENT LODGING OF A LOOSE POLISHING STONE IN THE LOCKING CHANNEL AFTER POLISHING. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THERE ARE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW DID NOT FIND ANY RELATED FAILURES.

Additional Manufacturer Narrative

H10: H2, H3, H6. THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION REVEALED NO ISSUES. A FUNCTIONAL EVALUATION FOUND THAT THE BLUE RING WOULDN'T LOCK DUE TO A POLISHING STONE FROM MANUFACTURING BEING STUCK IN THE QUICK CONNECT LOCKING CHANNEL. THE COMPLAINT WAS CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE AN INADVERTENT LODGING OF A LOOSE POLISHING STONE IN THE LOCKING CHANNEL AFTER POLISHING. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THERE ARE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A REVIEW OF THIS DEVICES MANUFACTURING PROCESS SHOWED THAT THE PUSH BUTTON MUST BE CHECKED FOR FREE MOVEMENT AND THAT IT LOCKS THE TOP PLATE. A COMPLAINT HISTORY REVIEW DID NOT FIND ANY RELATED FAILURES. A CORRECTIVE ACTION IN THE FORM OF A COMPLAINT NOTIFICATION HAS BEEN ISSUED TO THE MANUFACTURING GROUP REGARDING THIS ISSUE.