Description of Event or Problem · 1
A RESORBABLE MENISCUS REPAIR IMPLANT, BRANDED THE MENISCUS ARROW-R FROM BIONX IMPLANTS, INC, BLUE BELL, PA MAY HAVE A DESIGN PROBLEM THAT CAUSES THE DEVICE TO BREAK APART AND DISLODGE IN THE KNEE. THIS DEVICE IS USED FOR REPAIR OF VERTICAL, LONGITUDINAL MENISCUS TEARS IN THE VASCULAR ZONE. SEVERAL PEER REVIEWED JOURNALS - JOURNAL OF ARTHROSCOPY AND AMERICAN JOURNAL OF SPORTS MEDICINE, HAVE REPORTED ON THE DEVICE BREAKING IN THE KNEE JOINT FROM SURGICAL CASES OVER THE LAST SEVERAL YEARS. DEVELOPMENT ENGINEERS AND EXECUTIVES AT BIONX MAY KNOW THAT THE DESIGN COULD POTENTIALLY BE IMPAIRED AT ONE OF THE BARBS, WHICH ARE USED TO FIXATE THE IMPLANT TO THE TORN MENISCUS TISSUE. THIS DEVICE FAILURE CAN JEOPARDIZE THE REPAIR OF THE TORN MENISCUS TISSUE OF THE DEVICE BREAKS APART AND BECOMES A LOOSE BODY OF MATERIAL FLOATING IN THE JOINT. IF THE IMPLANT BECOMES A LOOSE BODY, ANOTHER SURGERY WOULD BE REQUIRED TO REMOVE THE BROKEN IMPLANT TO PREVENT ANY COLLATERAL DAMAGE FROM THE IMPLANT. IT IS BELIEVED THE CO HAS KNOWN FOR SEVERAL YEARS THAT THIS COULD POTENTIALLY BE AN ISSUE WITH THE DESIGN. TO RPTR'S KNOWLEDGE, A DESIGN PROBLEM ON THE MENISCUS ARROW HAS NEVER BEEN CONFIRMED OR STATISTICALLY PROVEN BY THE CO OR OUTSIDE SOURCES. IT HAS ONLY BEEN REPORTED IN THE PEER REVIEWED ARTICLES/LITERATURE DISCUSSED ABOVE. IT IS SUGGESTED THAT THE FDA SHOULD DO THE FOLLOWING: 1. SEE IF THE DESIGN ISSUE NEEDS CORRECTIVE ACTION. 2. IF DEFECTIVE, ENSURE THAT THE DEVICE IS BEING CORRECTED/MODIFIED BY BIONX TO MINIMIZE THE POTENTIAL FOR THIS TYPE OF FAILURE IN FUTURE SURGERIES. ENGINEERING PROJECT RECORDS MAY PROVIDE DATA AS TO WHEN THE CO KNEW THE DEVICE MAY HAVE DESIGN ISSUES AND WHAT STEPS, IF ANY, WERE SET IN PLACE TO CORRECT THE PROBLEM, IF ANY. PTS SHOULD NOT BE SUBJECT TO THIS TYPE OF RISK IF THE CO HAS LOCATED A DESIGN ISSUE, BUT HAS NOT ACTED TO CORRECT THE PROBLEM IN THE SURGICAL FIELD OR WITH INVENTORIES OUT IN THE FIELD. AT THE LEAST, THE PT SHOULD BE INFORMED BY THE CAREGIVER/SURGEON THAT THIS DEVICE, BEING A DELICATE, BUT CLINICALLY EFFECTIVE POLYMER IMPLANT FOR MENISCUS REPAIR COULD HAVE A POTENTIAL FOR BREAKING UNDER LOAD. THIS INFO SHOULD BE IN THE IMPLANTS PRODUCT INSERT SHEET AND COMMUNICATED TO ALL SURGEONS AND PTS. PROPER PRECAUTIONS SHOULD BE NOTED.