The company received notification on (b)(6) 2020 that a surgical instrument had a malfunction during a surgical procedure.It was reported that the distal end of a system inserter/compressor fractured when being used to compress implant plates.There were no known patient complications associated with this complaint.There was an alternate instrument available, which was used to successfully complete the procedure.A visual assessment of the returned inserter/compressor showed an instrument with repeated use, as identified by surface scratches, worn laser markings, and minor surface staining.The handle a tip was broken from the body of the instrument.The metal cylinder at the proximal end of the handle a tip was sheared off, leaving a portion of the fractured cylinder within the handle a main body.A functionality assessment could not be performed due to the broken condition of the instrument.A dhr review was performed for the complaint lot and the devices met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 12/19/18.It may be possible that application of excessive compression force may have contributed to the handle a tip fracturing from the instrument.The handle a tip is secured into the body of the instrument with a cylinder that has minor movement to allow for implant engagement.It may be possible that over compressing the instrument may concentrate applied force to the handle a tip, resulting in an instrument malfunction.
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