DIFFICULT TO SCREW THE DEVICE. IMPLANTATION WITH A PERPOS SYSTEM AS USUAL. WHILE TURNING THE SCREW HE REALIZED THAT THIS ONE WAS REALLY DIFFICULT TO SCREW. UNDER X-RAY VIEW, ONE COULD SEE THAT THE SCREW JUST FITTED SOMEWHAT AND THAT THE SCREW WAS SHORTENED AS WELL. THAT MEANS THE OUT PART HAD ALREADY CRIMPED WITH THE SCREW. A FURTHER TURNING NEITHER FORWARD OR BACKWARDS WAS POSSIBLE. THE PULL-PIN WAS TOO LONG. EVEN AFTER REMOVING THE PULL-PIN THE SCREW COULD ONLY BE UNSCREWED AND REPLACED WITH ANOTHER SYSTEM, WHICH COULD BE PLACED VERY WELL.
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Patient 1
ROOT CAUSE: PREMATURE COMPRESSION; THE CLIP WAS EITHER REMOVED TOO SOON OR THE INSTRUMENT WAS REMOVED FROM THE DEVICE AND THEN PLACED BACK ONTO THE DEVICE CAUSING IT TO COMPRESS PREMATURELY. EXPLANATION: ADDITIONAL TRAINING FOR THE CUSTOMER TO: THE CLIP CANNOT BE REMOVED TOO SOON. TO KEEP THE DEVICE AND DRIVER ENGAGED UNTIL THE DESIRED DEPTH. INITIALLY IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED. DEVICE EVALUATION: RETURNED IMPLANT WAS VISUALLY INSPECTED. DEVICE DID NOT REVEAL ANYTHING THAT WOULD LEAD TO PREMATURE DECOMPRESSION OF THE DEVICE. THE PULL PIN WAS SLIGHTLY BENT AND SCORED ON THE (B)(4) WHICH WAS LIKELY CAUSED DURING PIN REMOVAL.