PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE

Additional Manufacturer Narrative

THIS REPORT WAS NOT REPORTED TO FDA PREVIOUSLY BUT IT WAS FOUND REPORTABLE AFTER FDA INSPECTION(FORM 483) IN 2019. TOBY REQUESTED INFORMATION TO DETERMINE IF THE CORRECT SURGICAL PROCEDURE WAS USED AND THE METHOD OF FAILURE FOR THE SUTURE CLIP. THE SURGEON CONFIRMED THAT THE PLATE SYSTEM PERFORMED AS INTENDED FOR THE SURGERY, OTHER THAN THE REMOVAL OF SUTURE CLIP, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AT THIS TIME. AN INVESTIGATION WAS PERFORMED BY THE TOBY MEDICAL DIRECTOR PREVIOUSLY WITH SIMILAR COMPLAINTS IN 2013 AND FOUND THAT THE SURGEONS WERE USING A GRADE OF SUTURE WIRE MUCH LARGER THAN THE RECOMENDED SUTURE AND WERE POSSIBLY OVER MANIPULATING THE CLIPS DURING THE REDUCTION PROCESS. IT WAS CONFIRMED BY THE DISTRIBUTORS THAT TRAINING WAS PROVIDED TO THE SURGEONS BY TOBY MEDICAL DIRECTOR. BUT, INVESTIGATION COULD NOT BE COMPLETED AS WELL AS NO CONCLUSION COULD BE DRAWN AS THE DEVICE WAS NOT RETURNED. ALSO, LOT NUMBER WAS NOT PROVIDED. IF ANY INFORMATION WILL BE OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, WILL FILE A FOLLOW-UP MEDWATCH.

Description of Event or Problem

DURING A HUMERUS FRACTURE FIXATION SURGERY, A PANTERA SUTURE CLIP CAME OFF THE PLATE DURING SUTURING. THE CLIP WAS RECOVERED BY THE SURGEON AND THE SURGERY WAS COMPLETED SUCCESSFULLY. BUT, THIS ISSUE LED TO INCREASE THE SURGERY TIME BY FOUR HOURS AND 30 MINUTES.