Additional Manufacturer Narrative · 1
THE LUMBARTRAK BLADE WAS RETURNED BY THE DISTRIBUTOR. IT WAS ONE OF 374 VALVES, MEDICON REF 57.56.97, PRODUCED WITH LOT # 22 3M, PRODUCED FROM JULY TO SEPTEMBER 2006. OF THESE, SOME QUANTITY WERE SOLD TO JARIT/JAMNER. THIS IS ONE OF THE FIVE DEVICES (FROM TOTAL QUANTITY SOLD TO THE USA SINCE 2002) RETURNED IN SEPTEMBER 2007 DUE TO THE FRACTURE OR BREAKING OFF OF THE STUD (LOCATING BOLT) HOLDING THE VALVE. THE INTENSIVE INVESTIGATIONS SUBSEQUENTLY CARRIED OUT (SEE SUPPLEMENTAL REPORTS WITH DETAILED CAPA SUMMARY SUBMITTED 2/05/08) RESULTED IN A PARTIAL REDESIGN, TI MATERIAL CHANGE, AND DIFFERENT WELDING TECHNIQUE. THESE CHANGES HAVE SINCE BEEN APPROVED BY THE CUSTOMER AND HAVE BEEN IMPLEMENTED FOR THE PRODUCTION OF ALL NEW DEVICES. ACCORDING TO THE DISTRIBUTOR, A LARGE QUANITY DEVICES OF THE OLD DESIGN WERE STILL IN THE MARKET AT THAT TIME. TO PREVENT FUTURE OCCURRENCES AND THE RISK OF POSSIBLE PT INJURY, A REPLACEMENT/REVIEW ACTION WAS INITIATED, WITH THE LAST BATCH OF THESE DEVICES HAVING BEEN TESTED AND RETURNED TO THE CUSTOMER THE WEEK OF 6/9/08. (PLEASE SEE SUPPLEMENTAL REPORTS, "ADDITIONAL EVALUATIONS/INVESTIGATIONS PERFORMED", P. 3, OF 8010099-2007-00002 TO 8010099-2007-00005). THE MFR, IN COORDINATION WITH THE DISTRIBUTOR, BELIEVE THAT WITH THESE ACTIONS EVERYTHING HUMANLY POSSIBLE HAS BEEN DONE TO PREVENT FUTURE EVENTS.