ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Additional Manufacturer Narrative

PRODUCT ANALYSIS: MICROSCOPIC EXAMINATION APPEARS TO SHOW FAIRLY DUCTILE FRACTURE. MICROSCOPIC EXAMINATION APPEARS TO SHOW HELICAL FRACTURE WITH CIRCULAR MATERIAL FLOW WITH SHAFT ANGULATION, SUGGESTING TORSIONAL OVERLOAD WITH BENDING COMPONENT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH TORSIONAL OVERLOAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: HERNIATION. FOR WHICH PATIENT UNDERWENT ANTERIOR FUSION AT LEVEL C3-C4-C5. INTRA-OP, THE PREFIXATION PIN INSERTED IN THE HOLE OF CAUDAL SIDE WAS BROKEN DURING REMOVAL. AFTER PLACEMENT OF PLATE, PINS WERE INSERTED AT THE CRANIAL AND THE CAUDAL SIDES UNDER SURGICAL TECHNIQUE. THE PIN WAS INSERTED BY HAMMERING BECAUSE THE PATIENT¿S BONE WAS HARD. THE FLUOROSCOPIC IMAGE REVEALED THAT THE PIN THAT WAS INSERTED AT CAUDAL SIDE REMAINED A LITTLE BENT. THE PIN WAS BROKEN DURING PULLING OUT SO THE PLACED PLATE WAS REMOVED ONCE AND THE PIN WAS REMOVED USING HOSPITAL¿S DEVICE. AFTER THAT, THE PLATE WAS PLACED AGAIN AND FOUR SCREWS WERE INSERTED AND THEN THE SURGERY WAS FINISHED. THE PIN WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT¿S BODY. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT. DOCTOR'S COMMENT: IT OCCURRED POSSIBLY BECAUSE OF HAMMERING.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.