inforMED
MalfunctionISH

RUSH81

Received Jun 10, 2014 · Event occurred May 14, 2014

Report 3008584163-2014-00001 · MDR key 3916350

Device

Generic name

Prosthetic Foot

Model number

81

Catalog number

NA

Lot number

NA

Product problems

  • Break
  • Detachment Of Device Component
  • Defective Device

Patient

13 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

PER (B)(6)'S PROSTHETIST, ON (B)(6) 2014 ON A PHONE CALL CONVERSATION TO ABILITY DYNAMICS, THE FOLLOWING WAS REPORTED: (B)(6) WAS AT SCHOOL AND STOPPED TO TIE HIS SHOE. WHEN HE AROSE AND BEGAN TO HURRY TO CATCH UP WITH FRIENDS, HIS RUSH81 FOOT BROKE. WHEN THE LAST BOLT BROKE, THE UPPER PORTION OF THE BRACKET SEPARATED FROM THE KEEL OR UPPER COMPOSITE PIECE. THIS LEFT DAVID WITH ONLY A PORTION OF THE FOOT STILL ATTACHED TO HIS PROSTHESIS. DAVID STUMBLED, BUT THERE WAS NO REPORT OF HIM FALLING. THERE WERE NO INJURIES, AND TO THE BEST OF OUR KNOWLEDGE, (B)(6) DID NOT SEE A PHYSICIAN.

Additional Manufacturer Narrative

EMAIL SENT FROM (B)(4) (ABILITY) (B)(4) 2014. REQUESTED THE RETURN OF THE BROKEN RUSH81 FOOT WITH ALL COMPONENTS. TOLD (B)(6) HE WOULD BE INFORMED OF THE OUTCOME OF THE INVESTIGATION. TOLD (B)(6), ABILITY IS SENDING REPLACEMENT RUSH81 AND RUSH87 FEET TO SEE WHICH WORKS BEST. EMAIL SENT FROM (B)(6) 2014. RECEIVED THE FEET AND IS CALLING IN THE PATIENT. EMAIL SENT TO (B)(6) 2014: (B)(4) CONFIRMED THIS WAS COVERED BY WARRANTY. (B)(4) TOLD (B)(6) THERE WOULD BE A THOROUGH INVESTIGATION. (B)(4) ALSO EXPRESSED THAT ABILITY TAKES SAFETY VERY SERIOUSLY. EMAIL RECEIVED TO (B)(4) 2014: (B)(6) COMMUNICATED THAT HE SUCCESSFULLY INSTALLED, ONTO (B)(6), A RUSH87 REPLACEMENT FOOT ABILITY HAD SENT. PROSTHETIST AND PATIENT WERE PLEASED. CALL (B)(4) 2014: (B)(4). CONFIRMED EVERYTHING WENT WELL AND BOTH PROSTHETIST AND PATIENT ARE SATISFIED.

Remedial action

  • Replace