PICCOLO COMPOSITE ONE THIRD TUBULAR PLATE

Description of Event or Problem

THE PATIENT'S ULNA BONE WAS INITIALLY TREATED IN (B)(6) 2016 USING TWO CARBOFIX ONE THIRD TUBULAR PLATES. APPERANTLY, THE SURGEON DECIDED TO EXTEND ONE OF THE PLATES BY CONNECTING IT TO AN ADDITIONAL PLATE. THE TWO PLATES WERE IMPLANTED AS A SINGLE CONSTRUCT AND CONNECTED BY SCREWS INSERTED THROUGH OVERLAPPING ONE OR TWO HOLES OF BOTH PLATES. SIX YEARS POST-OPERATION, IN 2022 (EXACT DATE IS UNKNOWN), A REVISION SURGERY WAS PERFORMED AT A DIFFERENT MEDICAL CENTER DUE TO NON-UNION. THE CARBOFIX PLATES WERE REMOVED AND REPLACED WITH A SPANNING PLATE.

Additional Manufacturer Narrative

THE COMPANY FOUND OUT ABOUT THE CASE FROM A MESSAGE POSTED ON THE SOCIAL NETWORK. FOLLOWING THE MESSAGE, A COMPANY REPRESENTATIVE CONTACTED THE SURGEON FOR MORE DETAILS ON THE CASE. ACCORDING TO THE INFORMATION RECEIVED, THE COMPANY WAS ABLE TO LOCATE THE LOT NUMBERS OF THE INVOLVED PLATES. THE PLATES WERE NOT AVAILABLE FOR PHYSICAL EXAMINATION. NEVERTHELESS, EXAMINATION OF THE MANUFACTURING RECORDS OF THE INVOLVED PLATES INDICATED THEY WERE MANUFACTURED ACCORDING TO SPECIFICATION. THE COMPANY CAME TO A CONCLUSION THAT IT WAS AN IMPROPER USAGE OF THE PLATES (I.E. TWO PLATES WERE IMPLANTED AS A SINGLE CONSTRUCT AND CONNECTED THROUGH OVERLAPPING HOLES). SINCE THE INVOLVED PLATES WERE IMPLANTED AS A SINGLE CONSTRUCT, THE COMPANY IS SUMBITING A SINGLE REPORT. THE DETAILS OF THE SECOND INVOLVED PLATE: CATALOG #: POTTN2006, LOT #: 90744, EXPIRATION DATE: 31-JUL-2020, DEVICE MANUFACTURE DATE: 31-AUG-2015.