Description of Event or Problem · 1
THIS ALLEGED MEDICAL DEVICE MALFUNCTION WAS BROUGHT TO OUR ATTENTION BY A LETTER FROM THE PATIENT'S ATTORNEY ASKING FOR THIS DEVICE BECAUSE OF THEIR CLIENT'S POTENTIAL PRODUCT LIABILITY CLAIM ARISING FROM A FRACTURE IN THE SUPRACONDYLAR PLATE WHICH WAS INSERTED ON 2/20/91 AND REMOVED 12/3/91. THIS LETTER WAS BROUGHT TO MY ATTENTION AND INVESTIGATED 4/22/92. I HAVE BEEN TOLD THE PLATE WAS IN TWO PIECES, ONE THREE INCH SECTION AND ONE SECTION SEVEN INCHES OR LONGER. THE FRACTURE WAS AT A SREW HOLE. OUR PERSONNEL BELIEVED AT THE TIME OF REMOVAL, THE FRACTURED PLATE WAS CAUSED BY THE PATIENT'S OBESITY AND WEIGHT BEARING AND DID NOT CONSIDER IT A MALFUNCTION OR INJURY. THEREFORE, THEY DID NOT REPORT IT TO RISK MANAGEMENT AT THE TIME. THE EXTENT OF THE INJURY IS NOT KNOWN OTHER THAN ANOTHER PLATE WAS INSERTED AND THE FRACTURED PLATE REMOVED ON 12/3/91. THE CAUSE OF THE PLATE'S ALLEGED FRACTURE IS NOT KNOWN TO THIS HOSPITAL AS IT WAS NOT EVALUATED OR TESTED BY US BEFORE IT WAS TURNED OVER TO THE PATIENT'S ATTORNEY ON OR ABOUT APRIL 22, 1992. EDUCATIONAL SESSIONS WILL BE HELD IN SURGERY TO INFORM PERSONNEL THEY MUST REPORT IMPLANTED DEVICE REMOVAL IMMEDIATELY REGARDLESS OF PRECEIVED CAUSE OR ALLEGATION OF MALFUNCTIONDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.