QUADRA GENERAL SCREWED STEM EXTRACTOR M8

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 14-APR-2023. LOT 105239: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. HAVING NO PICTURES OF THE BROKEN SCREWED STEM EXTRACTOR M8 REF.01.10.10.003 LOT. 105239, WE DO NOT HAVE ENOUGH ELEMENTS FOR A DEFINITIVE ANALYSIS. THIS INSTRUMENT IS HIGHLY STRESSED DURING USE IN THE SURGICAL TECHNIQUE, WE CAN ASSUME A BREAKAGE DUE TO WEAR AS IT IS A 2010 BATCH WITH 13 YEARS OF USE.

Description of Event or Problem

WHEN THE SURGEON WAS TRYING TO EXTRACT THE STEM WITH THE STEM EXTRACTOR, THE SURGEON THREADED THE EXTRACTOR AND STARTED HAMMERING IT OUT AND THE TIP BROKE AND REMAINED IN THE STEM. THE SURGEON ATTEMPTED TO REMOVE THE INSTRUMENT TIP FOR 2 HOURS IN VARIOUS WAYS AND COULD NOT REMOVE IT. THE SURGEON COMPLETED THE SURGERY AND CLOSED THE PATIENT UP. THERE WAS A 2-HOUR DELAY AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. A CONSIGNMENT SET WAS USED.