4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE FOR A DISTAL FEMUR FRACTURE, THE SURGEON WAS COMPLAINING ABOUT THE PLATE FIT AND HOW FAR THE PLATE ON THE PLATE WAS SETTING OFF THE BONE. SHE ACCEPTED THE PLATE SETTING OFF THE BONE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). (B)(6). ADDITIONAL PRODUCT CODE: HWC HRS. 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.