UNKNOWN_ENDOSCOPY_PRODUCT

Additional Manufacturer Narrative

IT WAS REPORTED THIS COMPLAINT WAS INITIATED FROM A LITERATURE CASE STUDY AND THE DEVICE WILL NOT BE RETURNED TO STRYKER FOR FURTHER INVESTIGATION. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: LITERATURE PUBLICATION PROBABLE ROOT CAUSE: DESIGN POOR CONNECTOR DESIGNS OR TOLERANCING, CONNECTOR IS LOOSE, CONNECTOR UNABLE TO HOLD FORCE, UNCLEAR FEEDBACK IF MECHANISM IS FULLY LOCKED/ATTACHED, CASTERS SLIP ON FLOOR, VERTICAL SPARS COLLAPSE, HORIZONTAL SPARS COLLAPSE, FINE TRACTION ELEMENT PIVOTS UNINTENTIONALLY, BOOT DISCONNECTS FROM FINE TRACTION ELEMENT, TABLETOP EXTENSION CUSHION LIFTS OR SLIDES UNDER FORCE, USE ERROR.

Description of Event or Problem

PER LITERATURE PUBLICATION TITLED, "USE OF THE GUARDIAN TABLE EXTENSION DURING PERIACETABULAR OSTEOTOMY IS ASSOCIATED WITH AN INCREASED RISK OF INTRAOPERATIVE POSTERIOR COLUMN FRACTURES", BY TA-WEI TAI. THERE WAS A POSTERIOR COLUMN FRACTURES IDENTIFIED IN THE GUARDIAN TABLE GROUP. THIS CASE INVOLVED A 40-YEAR-OLD WOMAN WITH AN INITIALLY UNRECOGNIZED FRACTURE WHO REPORTED PERSISTENT ISCHIAL PAIN DURING RECOVERY. FOLLOW-UP IMAGING AT 7 MONTHS REVEALED A NONUNION. ALTHOUGH THE PATIENT HAD UNDERGONE SCREW FIXATION, THE SCREW FAILED WITHIN 2 MONTHS, NECESSITATING REVISION WITH PLATE FIXATION. DESPITE THIS INTERVENTION, UNION WAS NOT ACHIEVED AT 6-MONTH FOLLOW-UP AFTER PLATE FIXATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. THE PART NUMBER IS NOT KNOWN AT THIS TIME, THEREFORE THE GTIN AND 510K IS NOT KNOWN. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

Description of Event or Problem

PER LITERATURE PUBLICATION TITLED, "USE OF THE GUARDIAN TABLE EXTENSION DURING PERIACETABULAR OSTEOTOMY IS ASSOCIATED WITH AN INCREASED RISK OF INTRAOPERATIVE POSTERIOR COLUMN FRACTURES", BY TA-WEI TAI. THERE WAS A POSTERIOR COLUMN FRACTURES IDENTIFIED IN THE GUARDIAN TABLE GROUP. THIS CASE INVOLVED A 40-YEAR-OLD WOMAN WITH AN INITIALLY UNRECOGNIZED FRACTURE WHO REPORTED PERSISTENT ISCHIAL PAIN DURING RECOVERY. FOLLOW-UP IMAGING AT 7 MONTHS REVEALED A NONUNION. ALTHOUGH THE PATIENT HAD UNDERGONE SCREW FIXATION, THE SCREW FAILED WITHIN 2 MONTHS, NECESSITATING REVISION WITH PLATE FIXATION. DESPITE THIS INTERVENTION, UNION WAS NOT ACHIEVED AT 6-MONTH FOLLOW-UP AFTER PLATE FIXATION.