The manufacturer was made aware of a product complaint on (b)(6) 2022.It was reported that a system bone rongeur was identified as broken during a surgical procedure.The complainant stated that the surgeon used the bone rongeur, placed it on the mayo stand, and the next time he picked it up noticed a screw had come out of the instrument.There were no known patient complications associated with this complaint.An alternative available instrument was used to successfully complete the procedure.A return authorization number was issued for return of the complaint instrument, which was received at the manufacturer for complaint assessment on (b)(6) 2022.
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A visual assessment of the returned system bone rongeur showed an instrument with repeated use, as identified by surface scratches and worn altin coating.The distal cutting edges showed signs of wear and there was one screw missing from the instrument.The screw present near the missing screw was loose, and it took approximately two full rotations to tighten the loose screw.A functionality assessment was not performed due to the damaged condition of the returned system bone rongeur, which was removed from distributable inventory.A dhr review was performed for complaint instrument lot#: xs167883h and there were no manufacturing anomalies identified.The lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 9/16/2016.A system bone rongeur would not function as intended if one of the instrument screws was not present.It may be possible for a screw of a bone rongeur to come out of the instrument if it were loosened or previously removed.It is unknown why or how the screw of the bone rongeur was loosened.The system ifu provides guidance on cleaning of instruments, and states that, "no instruments within this system require disassembly as part of the cleaning process." the root cause of this complaint cannot be reliably determined.The complaint investigation suggests the screw of the instrument had come out of the bone rongeur due to being loosened or previously removed during the cleaning process.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
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