ORTHOSORB LS 1.3MM 3 PIN KIT

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 4 STATES, ¿CORRECT HANDLING OF IMPLANTS IS EXTREMELY IMPORTANT. DO NOT NOTCH OR BEND IMPLANTS. NOTCHES OR SCRATCHES PUT IN THE IMPLANT DURING THE COURSE OF SURGERY MAY CONTRIBUTE TO BREAKAGE. INTRAOPERATIVE FRACTURE OF DEVICES CAN OCCUR IF EXCESSIVE FORCE (TORQUE) IS APPLIED WHILE SEATING.¿ PRODUCT LOCATION UNKNOWN.

Description of Event or Problem

DURING AN ACETABULAR FRACTURE FIXATION PROCEDURE, TWO PINS FRACTURED. NO PATIENT INJURY OR DELAY WAS REPORTED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.