On (b)(6) a surgery took place for the implant of a fibular nail p/n 1527-225.
The sales representative reported that during the routine reaming of the fibula, the 3.
1 mm small bone reamer head fractured into multiple pieces (p/n 4020-031).
All but one piece was able to be retrieved.
The remaining piece was lodged in cortical bone, and the surgeon determined that retrieval of the remaining piece would cause more damage than good to the patient.
Though the lot number was retrieved from the broken reamer, the parts were not able to be returned for evaluation.
The parts were disposed of immediately after the surgery.
An engineering evaluation was unable to repeat the failure as described, and an exact root cause is unknown.
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