DRL 4.6X250MM STD CAN 3/16IN SQ

Description of Event or Problem

It was reported that during a surgical procedure, the surgeon was using a cannulated drill over a K-wire when the drill contacted an implanted screw and fractured. The K-wire was not damaged. The implanted screw that was contacted by the drill was subsequently removed and replaced. A fragment of drill debris remained within the patient. The event resulted in an approximately 25-minute delay to the procedure. No patient injury or adverse clinical outcome was reported. Attempts have been made and no further information has been provided.

Additional Manufacturer Narrative

(b)(4).H6: Proposed component code: Mechanical (G04) - Drill.The complaint is confirmed. Product evaluation verified the drill break. Review of the device history record(s) identified no deviations or anomalies during manufacturing. Medical records were not provided. The root cause of the reported event is attributed to unintended use error caused or contributed to event.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer Biomet will continue to monitor for trends.