Screw breaking during insertion was reported.The device was not returned for evaluation.The batch/lot number of the device is unknown; however, two possible batch/lot numbers were provided (1167694 or 1170533).Review of the device history records for the provided batch/lot numbers revealed no anomalies.A review of the complaint database was performed.A review for the part number 209-20xx part family revealed five (5) complaints for screws breaking during insertion (one of which is the complaint in this report).Potential causes for screws breaking during insertion include improper design, wrong size/length chosen for intended application, inadequate specifications for intended use, excessive torque used during insertion, high density bone, and improper material selection.However, based on the information received and the investigation performed, the root cause could not be determined.
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