6257 XPEDITION HIGH CONFIG

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 3 DEVICE(S) WAS/WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE(S) WAS/WERE REPAIRED AND RETURNED TO USE. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS) 1 DEVICE: GUIDE / DEFORMATION PROBLEM 1 DEVICE: LOCKING MECHANISM / DEFORMATION PROBLEM 1 DEVICE: RAIL / DEFORMATION PROBLEM. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. THIS REPORT SUMMARIZES 3 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.