Additional Manufacturer Narrative · 1
THE LUMBAR TRAK BLADE WAS RETURNED BY THE DISTRIBUTOR. IT IS ONE OF 353 BLADES, PRODUCED WITH LOT # 22 3M, PRODUCED FROM JULY 2006 TO SEPTEMBER 2006. OF THESE, A TOTAL OF 123 WERE SOLD TO THE DISTRIBUTOR. MEDICON HAS SOLD LARGE QUANTITY OF DIFFERENT SIZES TO THE US SINCE 2002. THE BLADE INVOLVED IS ONE OF SIX BLADES RETURNED, DUE TO THE FRACTURE OR BREAKING OFF OF THE STUD (LOCATING BOLT) HOLDING THE BLADE. THE BLADE WAS INCLUDED IN THE INTENSIVE INVESTIGATION CARRIED OUT FROM SEPTEMBER 07 TO JANUARY 08. THE RESULTS AND CAPA ACTIONS WERE REPORTED WITH MFR'S SUPPLEMENTAL REPORTS 8010099-2007-00002-5, SUBMITTED 2/5/08). RESULTS OF EVAL: THE BLADE INVOLVED HAS OBSERVABLE DEFORMATIONS IN THE AREA OF THE BLADE SHOULDERS. BASED ON OUR LONG-TERM EXPERIENCE AS QUALIFIED MFR OF SURGICAL INSTRUMENTS, WE ASSUME, THAT THE BLADE WAS PROBABLY OVERLOADED DUE TO EXCESSIVE FORCE APPLIED WHICH CAUSED THE BREAKING OFF OF THE STUD.