ADAPTABLE BEACH CHAIR

Description of Event or Problem

THE DEVICE WAS RECEIVED DAMAGED. THE HEADREST (TOP SECTION) WAS FRACTURED/DETACHED AT THE WELDED JOINT OF THE INNER NESTED CHANNEL ASSEMBLY (BC-0105), WHERE THE TOP SECTION CONNECTS TO THE MAIN BODY OF THE CHAIR. THE CONDITION WAS IDENTIFIED UPON DELIVERY, DURING ASSEMBLY, BEFORE ANY CLINICAL USE. NO PATIENT WAS INVOLVED AND NO INJURY OCCURRED. THE FAILURE MODE IS LOSS OF HEAD SUPPORT DUE TO FRACTURE OF THE BC-0105 WELD.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED AFTER THE 30-CALENDAR-DAY REPORTING TIMEFRAME REQUIRED UNDER 21 CFR 803.50. THE DELAY RESULTED FROM AN INITIAL REPORTABILITY DETERMINATION OF "NON-REPORTABLE" AT THE TIME OF COMPLAINT CLOSURE; THAT DETERMINATION HAS BEEN REASSESSED IN LIGHT OF THE MALFUNCTION RECURRENCE PATTERN ESTABLISHED ACROSS COMPLAINTS (b)(4), AND THIS REPORT REFLECTS THE CORRECTED DETERMINATION.THIS REPORT IS BEING SUBMITTED BASED ON A REASSESSMENT OF REPORTABILITY. AT THE TIME OF INITIAL COMPLAINT CLOSURE, THIS EVENT (DETACHMENT/BREAKAGE OF THE BEACH CHAIR HEADREST, LOT 2023020201, S/N (b)(4)) WAS EVALUATED AS AN ISOLATED, NON-REPORTABLE OCCURRENCE ATTRIBUTABLE TO SHIPPING DAMAGE. TWO SUBSEQUENT COMPLAINTS (COMPLAINTS (b)(4), CORRESPONDING MDR REPORT NUMBERS 3019856155-2026-00002 AND -00003) INVOLVING THE SAME FAILURE MODE - DETACHMENT OF THE HEADREST AT THE WELDED JOINT OF THE INNER NESTED CHANNEL ASSEMBLY (BC-0105) - ESTABLISHED A PATTERN MEETING THE MALFUNCTION RECURRENCE THRESHOLD UNDER 21 CFR 803.50. THIS REPORT REFLECTS THAT REASSESSMENT.ROOT CAUSE INVESTIGATION (CAPA-051) IDENTIFIED INCONSISTENT/INADEQUATE WELD QUALITY AT THE BC-0105 JOINT AS THE PRIMARY ROOT CAUSE, WITH CONTRIBUTING FACTORS OF PACKAGING-RELATED TRANSIT DAMAGE AND HEADREST DESIGN. CORRECTIVE ACTION CONSISTS OF A MODULAR TWO-PART REDESIGN ELIMINATING THE WELDED JOINT, WITH ASSOCIATED PACKAGING REDESIGN; DESIGN VERIFICATION IS IN PROGRESS UNDER DCO 1052. A FIELD CORRECTION ADDRESSING ALL AFFECTED UNITS (21 CFR PART 806) IS IN PROCESS; THE ASSOCIATED CORRECTION/REMOVAL REPORT IS PENDING SUBMISSION.NO INJURY OR DEATH OCCURRED IN ASSOCIATION WITH THIS EVENT. THIS COMPLAINT WAS DETECTED UPON DELIVERY, PRIOR TO ANY PATIENT CONTACT OR USE.