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Patient 1
REPORTED PRODUCT: 36-2002. DESCRIPTION: CLASSIC PLUS? NEEDLE HOLDER, CRILE-WOOD, 8 IN. DEAR VALUED CUSTOMER, SYMMETRY SURGICAL IS PROVIDING THIS SUMMARY IN RESPONSE TO THE INCIDENT INVOLVING THE CRILE-WOOD NEEDLE HOLDER. WE APOLOGIZE FOR ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED. THE QUALITY ASSURANCE INVESTIGATION IS COMPLETE WITH THE FOLLOWING RESULTS: UNFORTUNATELY, THE NEEDLE HOLDER WAS UNABLE TO BE RETURNED FOR A PHYSICAL EVALUATION. A REMOTE EVALUATION WAS ACCOMPLISHED USING PICTURES PROVIDED OF THE BROKEN INSTRUMENT. PICTURES SHOWED THAT A PIECE OF THE TUNGSTEN CARBIDE INSERT BROKE OFF THE NEEDLE HOLDER AND THAT THE INSTRUMENT HAD BEEN ETCHED WITH A MAY 2018 REPAIR CODE. SINCE THE LOT NUMBER WAS POLISHED OFF WE WERE UNABLE TO DETERMINE THE EXACT DATE THE INSTRUMENT WAS PURCHASED. WE SENT ALL PICTURES AND INFORMATION TO OUR REPAIR FACILITY, FIVE STAR, FOR INVESTIGATION. THEY CONFIRMED THAT THE REPAIR CODE ETCHED ON THE INSTRUMENT WAS THEIRS. THROUGH THEIR ASSESSMENT THEY DETERMINED THAT THE INSERT DID NOT FAIL DUE TO POOR WORKMANSHIP BUT LIKELY FAILED DUE TO A SMALL HAIR LINE CRACK IN THE INSERT. THE SMALL HAIR LINE CRACK LIKELY OCCURRED DUE TO EXCESSIVE FORCE OR IMPACT TO THE INSERT REGION, THEREFORE WEAKENING THE INSERT AND CAUSING IT TO PARTIALLY BREAK OFF IN THE MANNER DEPICTED IN THE PHOTOS. THANK YOU FOR YOUR PATIENCE DURING THE INVESTIGATION OF THIS ISSUE. IF YOU HAVE ANY QUESTIONS OR CONCERNS, PLEASE FEEL FREE TO CONTACT ME. (B)(4).