UNKNOWN_ENDOSCOPY_PRODUCT

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 A FEMALE WHERE IT WAS DETECTED ON IMMEDIATE POSTOPERATIVE RADIOGRAPHS. THIS PATIENT WAS PRESCRIBED AN ADDITIONAL FOUR WEEKS OF NON-WEIGHT-BEARING AMBULATION. THEY DEMONSTRATED SATISFACTORY HEALING ON FOLLOW-UP IMAGING WITHOUT FURTHER COMPLICATIONS.

Additional Manufacturer Narrative

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 COLLPSE, 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 A FEMALE WHERE IT WAS DETECTED ON IMMEDIATE POSTOPERATIVE RADIOGRAPHS. THIS PATIENT WAS PRESCRIBED AN ADDITIONAL FOUR WEEKS OF NON-WEIGHT-BEARING AMBULATION. THEY DEMONSTRATED SATISFACTORY HEALING ON FOLLOW-UP IMAGING WITHOUT FURTHER COMPLICATIONS.

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 510 IS NOT KNOWN. HOWEVER, SHOULD IT BECOME AVAILABLE, IT WILL BE PROVIDED IN FUTURE REPORTS.