TRACTION DEVICE MTD4000

Description of Event or Problem

ON (B)(6) 2013, I RECEIVED A COPY OF FDA FORM 3500A FROM THE FDA, THAT WAS INITIALLY SUBMITTED BY (B)(4)). THE FIRST NOTICE I RECEIVED REGARDING THIS UNIT (INCIDENT) WAS A PHONE MESSAGE ON (B)(6) 2013 FROM (B)(6). WHEN HER AND I SPOKE ON (B)(6) 2013 - SHE INFORMED ME THAT SHE HAD RECEIVED NOTIFICATION FROM SOMEONE (SHE COULD NOT TELL ME WHOM, FROM (B)(6) HOSPITAL) THAT A CABLE HAD BROKE, AT THE CLIP END, ON A (B)(4) TRACTION DEVICE. SHE DID NOT HAVE THE UNIT SERIAL NUMBER. I WAS TOLD THAT THE THERAPIST SET UP THE PATIENT FOR TREATMENT AND AT 17 LBS. THE CABLE RIPPED. THE ALLEGED UNIT WAS INSPECTED BY THE FACILITIES BIO-MED IN (B)(6) 2013 AND WAS OK. THERE WAS NO PATIENT INJURY. NO MEDWATCH REPORT WAS ISSUED AT THIS TIME AS THERE WAS NO PATIENT INJURY, THE UNIT WAS CHECKED OUT TO BE OK IN (B)(6) 2013 AND ONCE THE SERIAL NUMBER WAS DETERMINED, IT WAS NOTED THAT IT WAS VERY CLOSE TO THE 2 YEAR REQUIRED REPLACEMENT PERIOD FOR THE CABLE (PER THE MANUAL).

Additional Manufacturer Narrative

PER AN EMAIL FROM (B)(6) HOSPITAL ON (B)(4) 2013: A PATIENT WAS PLACED INTO A HARNESS FOR CERVICAL TRACTION. THE CABLE WAS PRETESTED FOR SLIPPING BY THE PHYSICAL THERAPIST. THE CABLE WAS ATTACHED TO THE HARNESS BY THE PT. AS THE CABLE WAS ATTACHED, THERE WAS NO NOTED ABNORMALITY OR FRAYING OF THE CABLE. THE TRACTION PULL WAS INITIATED. WHEN THE PULL REACHED ABOUT 17 LBS ON THE DIGITAL READOUT, THE CABLE BROKE FROM THE CLIP. THE TRACTION HARNESS WAS DISENGAGED FROM THE MOTOR SUDDENLY, CAUSING THE UNIT TO STOP PULLING IMMEDIATELY. THERE WAS NO PATIENT HARM.