SUPINE TABLE ATTACHMENT (A2) W/PAD

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, THE SUPINE TABLE BROKE WHILE PULLING TRACTION. THE PROCEDURE COULD NOT BE COMPLETED AND WAS RESCHEDULED. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).

Additional Manufacturer Narrative

H10 H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES IN THE ABSENCE OF THE REQUESTED MEDICAL DOCUMENTATION/AND OR CLINICAL FACTORS WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT COULD NOT BE DEFINITIVELY CONCLUDED, AND A CAUSAL RELATIONSHIP TO THE REPORTED EVENT COULD NOT BE CONFIRMED. THEREFORE, THE PATIENT IMPACT BEYOND TIME UNDER ANESTHESIA AND THE RESCHEDULING OF SURGICAL PROCEDURE CANNOT BE CONFIRMED NOR CONCLUDED. SHOULD ANY ADDITIONAL RELEVANT CLINICAL INFORMATION BE PROVIDED, THIS CASE WOULD BE RE-ASSESSED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.