BOOT ASSEMBLY, TRACTION DEVICE,OT 1000

Description of Event or Problem

BAXTER RECEIVED A REPORT FROM A DISTRIBUTOR NOTING IT WAS FOUND 2 NON-SERIALIZED TRACTION BOOTS FROM SAME LOT (23-268), WHERE THE BOOT BASE HAS BEEN INSTALLED IS FACING THE WRONG DIRECTION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

Additional Manufacturer Narrative

BAXTER RECEIVED A REPORT FROM A DISTRIBUTOR NOTING IT WAS FOUND 2 NON-SERIALIZED TRACTION BOOTS FROM SAME LOT (23-268), WHERE THE BOOT BASE HAS BEEN INSTALLED IS FACING THE WRONG DIRECTION. THERE WAS NO PATIENT/USER INJURY REPORTED. THE TRACTION BOOT IS USED FOR HIP SURGERY. THESE DEVICES ARE CAPABLE OF BEING USED WITH A BROAD PATIENT POPULATION AS DETERMINED APPROPRIATE BY THE CAREGIVER OR INSTITUTION. THE RETURN OF THE PRODUCT IS STILL IN PROCESS. NO FURTHER INFORMATION IS AVAILABLE ON THE INVESTIGATION OF THE DEVICE AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

BAXTER RECEIVED A REPORT FROM A DISTRIBUTOR NOTING IT WAS FOUND 2 NON-SERIALIZED TRACTION BOOTS FROM SAME LOT (23-268), WHERE THE BOOT BASE HAS BEEN INSTALLED IS FACING THE WRONG DIRECTION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

Additional Manufacturer Narrative

A SCAR ((B)(6)) WAS ISSUED TO THE SUPPLIER TO INVESTIGATE THE ISSUE AND AN NCR WAS GENERATED (PR (B)(4)). THE INITIAL INVESTIGATION BY THE SUPPLIER IDENTIFIED THAT THE HOLDING FIXTURE USED DURING MANUFACTURING ALLOWS THE MATERIAL TO BE LOADED UPSIDE DOWN AND THE CURRENT QUALITY INSPECTION STEPS ARE NOT ADEQUATE TO DETECT THIS DEFECT. A NEW QUALITY PROCESS WAS DEVELOPED TO DETECT THAT THE PARTS PASSED "ORIENTATED SO THAT THE PIN STARTS IN THE MIDDLE OF THE BOOT AND POINTS TOWARDS THE REAR" AFTER THE ASSEMBLY IS COMPLETED. IN ADDITION, THE DESIGN OF THE 10009192 TRACTION BOOTS WILL BE UPDATED SO THAT THE PIN ASSEMBLY CAN ONLY ASSEMBLED IN THE CORRECT ORIENTATION. A FIELD ACTION (FA-2024-009) WAS INITIATED TO RECALL THE INVOLVED DEVICES OF THIS NONCONFORMANCE DUE TO THE RISK OF THE DEVICE DETACHING FROM THE TRACTION SYSTEM AND RESULTING IN PATIENT HARM AND DELAY IN SURGERY. THE RECALLED DEVICES WILL THEN BE SCRAPPED AND HAVE BEEN REPLACED FOR THE CUSTOMER. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.