WASHER, BOLT, NUT, NON-SPINAL, CETALLIC

Additional Manufacturer Narrative

510K: THIS REPORT IS FOR AN UNKNOWN WASHER. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA ON AN UNKNOWN DATE. THE ORIGINAL CONSTRUCT INCLUDED ONE (1) 4.5MM LATERAL PROXIMAL TIBIA PLATE, SIX (6) SCREWS IN THE PLATE AND ONE (1) INDEPENDENT 7.3MM CANNULATED SCREW WITH A WASHER. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PAIN AT THE MEDIAL SIDE OF THE TIBIA, WHERE THE INDEPENDENT 7.3MM CANNULATED SCREW HAD BEEN IMPLANTED. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR HARDWARE REMOVAL. THE SURGEON WAS ABLE TO REMOVE THE 7.3MM CANNULATED SCREW AND WASHER AND TWO (2) PROXIMAL LOCKING SCREWS IN THE PLATE -ALL INTACT. ONE (1) PROXIMAL SCREW STRIPPED AND THE SURGEON DECIDED TO STOP TRYING TO REMOVE HARDWARE. THE STRIPPED SCREW REMAINED IMPLANTED. RETAINED HARDWARE INCLUDED THE 4.5MM LATERAL PROXIMAL TIBIA PLATE, ONE (1) PROXIMAL SCREW AND THREE (3) DISTAL SCREWS. ALL HARDWARE WAS INTACT. THERE WAS NO REPORTED SURGICAL DELAY, AND NO ADDITIONAL X-RAYS OR ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE PROXIMAL SCREW THAT STRIPPED IS REPORTED IN (B)(4). THIS REPORT IS FOR ONE (1) WASHER. THIS IS REPORT 2 OF 4 FOR (B)(4).