HI-LINE XS DIAMOND BURR II D1.4MM

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS A SIMILAR DEVICE REPORT, A SIMILAR DEVICE OF THE REPORTED DEVICE WAS SOLD TO US THE REPORTED DEVICE IS NOT MARKETED IN THE US.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GE512R - HI-LINE XS DIAMOND BURR II D1.4MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INSTRUMENT WAS USED DURING NEURO SURGERY/ SPINE SURGERY. THE TIP WAS DAMAGED DURING CUTTING. THE AIR PRESSURE AT THE TIME OF USE WAS SEVEN BAR. THE NUMBER OF TIMES THE BAR WAS USED IS UNKNOWN. CUSTOMERS WERE USING IT WITH A LITTLE PUSH. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

THIS IS A SIMILAR DEVICE REPORT, A SIMILAR DEVICE OF THE REPORTED DEVICE WAS SOLD TO US THE REPORTED DEVICE IS NOT MARKETED IN THE US INVESIGATION: THE DIAMOND MILL SHOWS SURFACE CHANGES AT THE WORKING END. THE TIP OF THE MILL IS BROKEN OFF THE SHAFT. DEEP SCRATCHES NEAR THE TIP ARE VISIBLE. ACCORDING TO THE INSTRUCTION MANUAL, FUNCTIONAL CHECKS ARE REQUIRED AND DESCRIBED. IN ADDITION, IN WORKING WITH ROTATING TOOLS IT IS NOTED THAT THERE ARE SOME RISKS OF INJURY AND DAMAGE TO THE TOOL/SYSTEM. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. NO SIMILAR COMPLAINTS WERE FOUND IN THE SYSTEM. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE; SEVERITY WAS 3(5) AND PROBABILITY 2(5) . EXPLANATION AND RATIONALE: THE DEFECT COMPLAINED BY THE CUSTOMER COULD BE CONFIRMED. THE DIAMOND BALL ON THE TIP OF THE MILL IS BROKEN OFF. ON THE SURFACE ARE DEEP SCRATCHES THAT INDICATE A MISUSE OF THE DIAMOND MILLING CUTTER. IN ADDITION, THERE IS AN ANNEALING COLOR DUE TO OVERHEATING OF THE MILL. THESE DAMAGES ARE CAUSED BY INCORRECT HANDLING OF THE USER. DURING USE THE MILL MUST BE IN CONTACT WITH VERY HARD MATERIAL LIKE "METAL" TO GET THE SCRATCHES AND ANNEALING COLOR. IN ADDITION, THERE MUST BE TOO HIGH PRESSURE ON THE WORKING END. CONCLUSION/PREVENTIVE MEASURES: BASED UPON INVESTIGATION RESULTS, THE MOST PROBABLE ROOT CAUSE IS HANDLING - RELATED. BASED UPON INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.