DELTA TWIST

Additional Manufacturer Narrative

DEVICE IS CURRENTLY NOT AVAILABLE FOR EVALUATION (NOT RETURNED FROM THE CUSTOMER YET); SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER EVALUATION OF ALL DEVICE COMPONENTS IS COMPLETED.

Description of Event or Problem

THIS COMPONENT WAS DAMAGED IN A MOTORCYCLE ACCIDENT ON (B)(6) 2017. CUSTOMER ATTEMPTED TO SERVICE IT BUT WAS UNABLE TO GET GOOD RESULTS: ROTATION FEATURE IS STUCK. COMPRESSION - UNABLE TO ADJUST. THIS JOB CAME IN WITH ANOTHER, A 3R60 - MODULAR POLYCENTRIC EBS KNEE JOINT (ALSO RETURNED ON NOTIFICATION 600507558: "CLIENT WAS INVOLVED IN A MOTORCYCLE ACCIDENT (B)(6) 2017. FOUR BOLTS IN KNEE CAME LOOSE AND 2 FELL OUT COMPLETELY. FRAME SEEMS TO HAVE BEEN TWISTED. UNABLE TO INSTALL BOLTS AGAIN.") RELATED TO THE SAME MOTORCYCLE ACCIDENT. WHILE THE CUSTOMER INDICATED THE 4R120 WAS NOT THE CAUSE OF THE FALL, THEY ARE INDICATING THAT THE 3R60 WAS.

Additional Manufacturer Narrative

EVALUATION AND INVESTIGATION OF THE KNEE JOINT SHOWED NO RELEVANT ERROR WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE OCCURRED EVENT.

Description of Event or Problem

THIS COMPONENT WAS DAMAGED IN A MOTORCYCLE ACCIDENT ON (B)(6) 2017. CUSTOMER ATTEMPTED TO SERVICE IT BUT WAS UNABLE TO GET GOOD RESULTS: - ROTATION FEATURE IS STUCK; - COMPRESSION - UNABLE TO ADJUST; THIS JOB CAME IN WITH ANOTHER, A 3R60 - MODULAR POLYCENTRIC EBS KNEE JOINT (ALSO RETURNED ON NOTIFICATION (B)(4): "CLIENT WAS INVOLVED IN A MOTORCYCLE ACCIDENT (B)(6) 2017. 4 BOLTS IN KNEE CAME LOOSE AND 2 FELL OUT COMPLETELY. FRAME SEEMS TO HAVE BEEN TWISTED. UNABLE TO INSTALL BOLTS AGAIN.") RELATED TO THE SAME MOTORCYCLE ACCIDENT. WHILE THE CUSTOMER INDICATED THE 4R120 WAS NOT THE CAUSE OF THE FALL, THEY ARE INDICATING THAT THE 3R60 WAS. FURTHER INFORMATION RECEIVED ON 2018-02-02: OTTOBOCK MADE ADDITIONAL CONTACT WITH THE PRACTITIONER TO FURTHER CLARIFY THE DETAILS OF THIS EVENT. IT WAS DETERMINED THAT DURING INITIAL CONTACT TO OTTOBOCK EVENT DETAILS WERE MIS-INTERPRETED. THE PRACTITIONER CORRECTED THE EVENT DETAILS BY REPORTING HIS PATIENT DID NOT EVER STATE THAT THE 3R60 WAS THE CAUSE OF THE CRASH. ALSO CORRECTED BY THE PRACTITIONER, IS THAT THE PATIENT WAS DRIVING HIS MOTORCYCLE AND A DEER JUMPED OUT IN THE ROAD CAUSING HIM TO VEER OFF THE ROAD AND CRASH. THIS CRASH WAS CAUSED BY THE DEER IN THE ROAD AND NOT THE PROSTHETIC DEVICES IN USE.

Additional Manufacturer Narrative

EVALUATION AND INVESTIGATION OF THE KNEE JOINT SHOWED NO RELEVANT ERROR WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE OCCURRED EVENT.

Description of Event or Problem

THIS COMPONENT WAS DAMAGED IN A MOTORCYCLE ACCIDENT ON (B)(6) 2017. CUSTOMER ATTEMPTED TO SERVICE IT BUT WAS UNABLE TO GET GOOD RESULTS: ROTATION FEATURE IS STUCK COMPRESSION - UNABLE TO ADJUST. THIS JOB CAME IN WITH ANOTHER, A 3R60 - MODULAR POLYCENTRIC EBS KNEE JOINT (ALSO RETURNED ON NOTIFICATION 600507558: "CLIENT WAS INVOLVED IN A MOTORCYCLE ACCIDENT (B)(6) 2017. 4 BOLTS IN KNEE CAME LOOSE AND 2 FELL OUT COMPLETELY. FRAME SEEMS TO HAVE BEEN TWISTED. UNABLE TO INSTALL BOLTS AGAIN.") RELATED TO THE SAME MOTORCYCLE ACCIDENT. WHILE THE CUSTOMER INDICATED THE 4R120 WAS NOT THE CAUSE OF THE FALL, THEY ARE INDICATING THAT THE 3R60 WAS. FURTHER INFORMATION RECEIVED ON 2018-02-02: ACCORDING TO (B)(4), THE CUSTOMER DID NOT EVER STATE THAT THE 3R60 WAS THE CAUSE OF THE FALL. THIS WAS MIS-INTERPRETED DURING THE INITIAL CONTACT FROM THE CUSTOMER. INSTEAD, (B)(4) FOUND THAT WHILE THE PATIENT WAS DRIVING HIS MOTORCYCLE A DEER JUMPED OUT IN THE ROAD CAUSING HIM TO VEER OFF THE ROAD AND CRASH. THIS CRASH RESULTED IN SIGNIFICANT FRACTURES AND HOSPITALIZATION WAS REQUIRED.