CARROLL-GIRARD SCREW HEX-END

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

Additional Manufacturer Narrative

A PHOTOGRAPH WAS PROVIDED WHICH CONFIRMS THE DEVICE IS FRACTURED. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

IT WAS REPORTED DURING AN OPEN REDUCTION AND INTERNAL FIXATION FOR ZYGOMATIC ARCH PROCEDURE A SCREW BROKE. THE REMAINING SCREW WAS REMOVED USING A DIAMOND BAR. A SURGICAL DELAY OVER 30 MINUTES WAS REPORTED, HOWEVER THE EXACT DELAY IS UNKNOWN. THE PATIENT DID NOT RETAIN A FOREIGN BODY.

Additional Manufacturer Narrative

THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE PRODUCT WAS VISUALLY EVALUATED AND WAS SEEN TO BE FRACTURED. THERE IS A SLIGHT BEND LEADING INTO THE FRACTURE SIGHT WHICH IS EXPECTED AS THERE WAS PLASTIC DEFORMATION JUST PRIOR TO FULLY FRACTURING. THERE IS TISSUE REMAINING IN THE THREADS, BUT THE THREAD FORM IS CLEAN WITH THE EXCEPTION OF THE AREAS AFFECTED DURING REMOVAL WITH THE DIAMOND BAR. THE MOST LIKELY CAUSE OF THIS IS DETERMINED TO BE EXCESSIVE FORCE ON AN OFF AXIS ANGLE WHILE ATTEMPTING TO APPROXIMATE TIGHTLY POSITIONED BONE FRAGMENTS. INSTRUCTIONS FOR USE STATE, "AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS." THE NON-CONFORMANCE DATABASE WAS REVIEWED AND THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS PRODUCT.