PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE

Description of Event or Problem

DISTAL SCREW FIXATION FAILED. MEDICAL EXPERTS AGREED THAT THE CAUSE WAS LIKELY A TRAUMA EVENT/FALL, BUT THE PT SAID THAT NO TRAUMA OCCURRED. PROXIMAL FIXATION INTO THE HUMERAL HEAD REMAINED INTACT, BUT REVISION SURGERY WAS REQUIRED DUE TO THE LOSS OF FIXATION IN THE DISTAL LOCKING SCREWS FROM THE SHAFT. THE DEVICE WAS INTACT AND SHOWED NO SIGNS OF FATIGUE OR FRACTURE. THE BONE ITSELF, MORE SPECIFICALLY, THE SCREW-BONE INTERFACE (ALONG THE DIAPHYSIS) FAILED MOST LIKELY FROM A COMBINATION OF SEVERE OSTEOPOROSIS AND TRAUMA. THE DEVICE WAS NOT AVAILABLE FOR TESTING AFTERWARDS.

Additional Manufacturer Narrative

THIS REPORT WAS MISTAKENLY REPORTED ON THE FORM 3500 VOLUNTARY EVENT REPORTING DOCUMENT ON (B)(4) 2012, AND IS NOW BEING RESUBMITTED IN RESPONSE TO AN FDA INSPECTION 483 ITEM. A TOBY SALES REP INITIALLY REPORTED THE INCIDENT TO THE TOBY MEDICAL DIRECTOR ON THE DATE NOTED ABOVE. THE TOBY MEDICAL SPOKE WITH THE ACTING SURGEON AND WAS INFORMED THAT THE PANTERA PLATE SCREW HAD LOST FIXATION ON THE DISTAL PORTION OF THE SHAFT. THE CAUSE OF THE MALFUNCTION WAS THOUGHT TO BE A TRAUMATIC EVENT BECAUSE THERE WERE NO SIGNS OF FATIGUE OR SIGNS OF A GRADUAL LOSS OF FIXATION. IN ADDITION, THE FIXATION AT THE HUMERAL HEAD WAS STILL PERFECTLY INTACT, WHICH DID NOT SEEM NORMAL TO THE MEDICAL EXPERTS. HOWEVER, IT WAS NOTED THAT THE PT STATED THAT SHE DID NOT FALL OR CAUSE TRAUMA TO THE IMPLANT AREA TO CAUSE THE MALFUNCTION, AND IT WAS ALSO NOTED BY THE SURGEON THAT THE PT HAD VERY OSTEOPOROTIC BONE IN THE FRACTURE AREA. THE PLATE WAS EXAMINED AT THE HOSPITAL FACILITY AND WAS DISCARDED BY THE SURGICAL STAFF PRIOR TO ANY POTENTIAL INVESTIGATION TAKING PLACE BY TOBY. THE SURGEON AND SALES REP SAID THAT THERE WERE NO SIGNS OF DAMAGE TO THE DEVICE, ONLY THAT THE DISTAL SCREWS HAD MIGRATED AWAY FROM THE DIAPHYSIS. NO LONG TERM PT INJURY OR DISCOMFORT WAS NOTED.