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Additional Manufacturer Narrative

THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.

Description of Event or Problem

ON 08/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1627 BEACH CHAIR POSITIONER HAD AN ISSUE. THE BEACH CHAIR POSITIONER WOULD NOT HOLD THE PATIENT IN POSITION. HE DID NOT EXCEED THE WEIGHT LIMIT. THEY WERE ABLE TO USE ANOTHER BEACH CHAIR TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.