A visual assessment of the returned complaint inserter showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The lip at the distal tip of one inserter arm was fractured, and instructional laser markings (e.G., final locking) was visible and easy to identify.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable goods.A dhr review was performed for the device lot and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 4/15/2016.The distal tip of one of the system inserter arms could break if excessive force was placed on the implant/instrument interface.The arm of the instrument that broke is intended to temporarily secure the implant cross bar plate for placement.Final tightening is completed by tightening the implant set screw on the implant locking plate via the other instrument arm, which is appropriately laser marked.If the set screw that temporarily secures the cross bar plate to the inserter is rotated beyond what is required, it will transfer the excessive force to the distal tip and can result in the observed instrument malfunction.The root cause of this complaint is rotating the incorrect screw on the inserter, which resulted in excessive force applied to the implant/inserter interface.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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The manufacturer was made aware of a system inserter malfunction on (b)(6) 2022.It was reported that the distal tip of one of the instrument arms fractured during a surgical procedure.There were no known patient complications associated with this complaint.Alternate available instruments were used to successfully place and compress the implant construct, with reported good placement.A replacement instrument was provided to the complainant and a return authorization was issued for return of the complaint instrument, which was received at the manufacturer on 7/26/2022 for complaint assessment.
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