NUVASIVE GENERAL INSTRUMENTS

Description of Event or Problem

ON (B)(6) 2023 A PATIENT UNDERWENT A DISCECTOMY PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING DISC REMOVAL THE UPPER INSTRUMENT JAW FRACTURED OFF AFTER BEING WEDGED IN-BETWEEN THE VERTEBRAL BODIES. THE FRACTURED PORTION WAS REMOVED FROM THE PATIENT WITH ANOTHER INSTRUMENT AND THE SURGERY WAS COMPLETED WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCES REPORTED AND NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED BY NUVASIVE ITALY WHO PROVIDED PHOTOGRAPHS AND THE COMPLAINT WAS CONFIRMED. REVIEW OF THE PROVIDED PHOTOGRAPH IDENTIFIED THE UPPER BITING JAW FRACTURED OF RIGHT AT THE HINGE FEATURE AND IS CONSISTENT WITH OFF ANGLED EXCESSIVE FORCE. REVIEW OF THE MANUFACTURING HISTORY IDENTIFIED LOT FD2909221 WAS RELEASED TO THE FIELD ON MAY 28, 2021 AS PART OF LOANER SETS THAT ARE SUBJECTED TO HANDLING AND REPEATED STERILIZATION CYCLES AFTER DISTRIBUTION INTO THE FIELD WHERE WEAR FATIGUE AND DAMAGE CAN OCCUR OVER TIME AND CONSIDERED THE ROOT CAUSE. REVIEW OF THE DEVICE HISTORY RECORD NOTES NO MATERIAL NON-CONFORMANCE, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE. LABELING REVIEW: "...WARNINGS, CAUTIONS AND PRECAUTIONS: COMPLICATIONS TO THE HOSPITAL STAFF MAY INCLUDE, BUT ARE NOT LIMITED TO: INJURY THAT MAY RESULT FROM INSTRUMENT BREAKAGE, SLIPPAGE, MISUSE, OR MISHANDLING. PRE-OPERATIVE WARNINGS: THE METHOD OF USE FOR THE INSTRUMENTS ARE TO BE DETERMINED BY THE USER¿S EXPERIENCE AND TRAINING IN SURGICAL PROCEDURES... THE INSTRUMENTS SHOULD BE TREATED AS ANY PRECISION INSTRUMENT AND SHOULD BE CAREFULLY PLACED ON TRAYS, CLEANED AFTER EACH USE, AND STORED, ACCORDING TO GENERALLY ACCEPTED HOSPITAL METHODS AND PRACTICES. THE INSTRUMENTS SHOULD BE CAREFULLY EXAMINED PRIOR TO USE FOR FUNCTIONALITY, EXCESSIVE WEAR, OR DAMAGE. A DAMAGED INSTRUMENT SHOULD NOT BE USED AS THIS MAY INCREASE THE RISK OF MALFUNCTION AND POTENTIAL PATIENT INJURY..." "...INTRA-OPERATIVE WARNINGS: THE PHYSICAL CHARACTERISTICS REQUIRED FOR MANY INSTRUMENTS DO NOT PERMIT THEM TO BE MANUFACTURED FROM IMPLANTABLE MATERIALS. IF ANY BROKEN FRAGMENTS OF INSTRUMENTS REMAIN IN THE BODY OF A PATIENT, THEY COULD CAUSE ALLERGIC REACTIONS OR INFECTIONS. IF AN INSTRUMENT BREAKS IN SURGERY AND FRAGMENTS GO INTO THE PATIENT, THESE PIECES SHOULD BE REMOVED PRIOR TO CLOSURE AND SHOULD NOT BE IMPLANTED..." DEVICE NO RETURNED.