Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). ACCORDING TO THE INFO RECEIVED FROM THE DISTRIBUTOR (B)(4), THE HEALTHCARE FACILITY REPORTS THAT THE PHYSICIAN HANDED THE INSTRUMENT OFF TO THE SCRUB TECH STATING IT WAS BROKEN. WHEN EXAMINED IT WAS NOTED THAT THE SCREW WAS FOUND TO BE MISSING. THE PHYSICIAN WAS NOTIFIED, X-RAY TAKEN, AND REPORTED AS NEGATIVE. NO PT HARM. CONCLUSION: THE THREAD OF THE SCREW IN THE MAIN PART OF THE HANDLE MEETS THE SPECIFICATIONS. AS TO WHY THE SCREW BECAME LOOSE CANNOT BE DETERMINED, SINCE THE SCREW WAS NOT RETURNED FOR INVESTIGATION. IF THE SCREW WOULD HAVE BEEN INCLUDED FOR INVESTIGATION, WE COULD HAVE POSSIBLY FOUND ANY INFO WHETHER, FOR EXAMPLE, THE SCREW WAS UNTIGHTENED BY A REPAIR SERVICE. SEE SCANNED PAGES.