ACCULAN 3TI DERMATOME
Received Aug 21, 2015
Report 2916714-2015-00728 · MDR key 5032867
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
US REPORTING AGENT NOTIFIED ON: (B)(6)2015. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). DERMATOME DOES NOT CUT PROPERLY DURING SURGERY.
Additional Manufacturer Narrative
(B)(4). MANUFACTURING SITE EVALUATION: THE PRODUCT WAS RETURNED TOGETHER WITH THE BATTERY LID. A FUNCTIONAL TEST (WITHOUT LOAD) WAS PERFORMED. A (B)(4) WAS INSERTED INTO THE DERMATOME TO PERFORM THE FUNCTIONAL INSPECTION. THE OPERATION SPEED OF THE PRODUCT (RPM) WAS 6400 RPM; WHICH IS WITHIN SPECIFICATION (6500 RPM, +/- 10%). THE OPERATION NOISE WAS NOT UNUSUAL. A VISUAL INSPECTION OF THE PRODUCT WAS PERFORMED. THE FLAP BAR IS BENT AND DIFFICULT TO DISASSEMBLE. SCREWS AT THE CLAMPING LEVER WERE LOOSENED. THE METERING BAR AS WELL AS THE BLADE GUIDANCE ARE STRONGLY DENTED ON ONE SIDE. THE CUT SETTING IS NO LONGER CORRECT AND NO LONGER MEETS THE SPECIFICATIONS, DUE TO THE DEFORMATION AND DAMAGES TO THE PARTS MENTIONED ABOVE. THIS HAS BEEN VERIFIED BY USING GAUGES. A TEST OF THE CUTTING FUNCTION (WITH TEST MATERIAL) WAS NOT POSSIBLE, DUE TO THE DAMAGE PRESENT. A REVIEW OF THE MANUFACTURING RECORDS DOES NOT SHOW ANY DEVIATIONS FROM SPECIFICATION. ALL TESTED MACHINES WERE DOCUMENTED WITH CORRECT PERFORMANCE VALUES. ALSO, THE FUNCTIONAL INSPECTION WAS SUCCESSFUL ON EACH DEVICE TESTED. THERE IS NO OTHER COMPLAINT IN THE COMPLAINT DATABASE FOR THE SAME BATCH NUMBER (TIME FRAME 01-01-2010 TO 11-16-2015. THERE IS NO COMPLAINT FOR A DEVICE WITH A SIMILAR SERIAL NUMBER FILED IN THE COMPLAINT DATABASE IN THE SAME TIME FRAME. THE DEFECTS ON THE PRODUCT ARE HANDLING RELATED. THE DEFORMATION AND DENTS DETECTED ON THE DERMATOMES WORKING END / HEAD INDICATE THE PRODUCT WAS DAMAGED BY HITTING ON A HARD SURFACE (E.G. DISCARDING AFTER USAGE AND HITTING ON THE DERMATOME HEAD) OR BY DROP DOWN DAMAGE (E.G. DURING REPROCESSING / HANDLING). CLEAR INDICATORS FOR THIS ROOT CAUSE ARE THE DENTS ON ONE SIDE OF THE METERING BAR AND THE BLADE GUIDANCE; SUBSEQUENTLY, THE SCREWS AT THE CLAMPING LEVER LOOSENED. IT WAS NOT POSSIBLE TO RELATE THE DEFECTS DETECTED ON THE PRODUCT TO A MANUFACTURING FAILURE OR A MATERIAL DEVIATION. CORRECTIVE / PREVENTATIVE ACTION(S) ARE NOT NECESSARY.