IT WAS REPORTED ON (B)(6) 2013, TWO COMPARTMENTAL PRESSURE MONITORING SYSTEM PROBES FAILED DURING A DEMONSTRATION TEST ON A (B)(6) OLD FEMALE AT THE OFFICE OF A SURGEON. THE FIRST PROBE RECORDED PROBE MALFUNCTION ON THE FIRST ATTEMPT; THE SECOND ATTEMPT SHOWED A 0.0 READING. THE PROBE FUNCTIONED ON THE THIRD ATTEMPT. THE SECOND PROBE DID NOT PRODUCE ANY READINGS. BOTH PROBES WERE REPORTED TO BE AT APPROXIMATELY TWENTY OF THE TWENTY-FIVE AVAILABLE READINGS. IT WAS REPORTED THAT THE TEST RESULT WAS NEGATIVE WITH A READING OF 14 TO 15 MMHG AND THAT THERE WAS NO IMPACT TO THE PATIENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
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Patient 1
THIS DEVICE IS USED FOR DIAGNOSIS, NOT TREATMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE LOT NUMBER INDICATED ((B)(4)) ON THIS COMPLAINT, FOR P/N 530.412, FOR THE PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM, CANNOT BE CROSS-REFERENCED TO A SYNTHES LOT NUMBER. THEREFORE, IT IS NOT POSSIBLE TO PERFORM A DHR REVIEW FOR THIS COMPLAINT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. PLACEHOLDER.
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Patient 1
THIS DEVICE WAS USED FOR DIAGNOSIS, NOT TREATMENT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # US-20-1804 REVEALED THE PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM FOR 530.412 WAS MANUFACTURED BY MAMMENDORFER INSTITUTE, WAS RECEIVED ON PO # (B)(4) DATED 8/8/12 FOR 1 PART, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION ?B? ON 8/9/12. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (C OF C) IS DATED 7/27/12. 1 PART WAS RELEASED TO THE WAREHOUSE ON 8/13/12. NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT.
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Patient 1
THIS DEVICE WAS USED FOR DIAGNOSIS, NOT TREATMENT. ADDITIONAL NARRATIVE: MANUFACTURING EVALUATION INDICATED (B)(4) MANUFACTURED THE PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM, P/N 530.412, LOT US-20-1804. THE LOT WAS MANUFACTURED TO THE SYNTHES SOURCE CONTROL DRAWING. THE LOT WAS PROCESSED PER SPECIFICATION REQUIREMENTS, AND PREVIOUSLY 100 PERCENT INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET. THE COMPLAINT ISSUE WAS DUE TO AN UNKNOWN CAUSE. THE RESPONSE OF (B)(4) DATED SEPTEMBER 13, 2013, STATED THE FOLLOWING: DEFECT: SOILED MEMBRANE OF BOTH PROBES. THE MEMBRANE OF BOTH PROBES IS SOILED. THEREFORE, THE OFFSET IS NOT STABLE AND OUT OF TOLERANCE. THE PROBES WERE NOT PROPER(LY) CLEANED AFTER USAGE.