SAFETY SCALPEL

Additional Manufacturer Narrative

ROOT CAUSE: THE SCALPEL IS SUPPLIED TO DEROYAL BY S&S SURGICAL. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO THE SUPPLIER. IN ITS RESPONSE, THE MANUFACTURER INDICATED A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE DEFECTIVE SAMPLES WERE NOT AVAILABLE FOR EVALUATION. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THAT, WHEN UNPACKING BOXES OF A PRODUCT (FINISHED GOOD (B)(4)), THE SCALPEL BLADES WERE NOT FULLY RETRACTED, CREATING A DANGER TO STAFF. THE INVESTIGATOR REVIEWED THE PURCHASE ORDER FOR POSSIBLE DISCREPANCIES. NO DISCREPANCIES WERE IDENTIFIED. THE SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS DURING THE TIME PERIOD OF 2015-2017. SIMILAR COMPLAINTS WERE IDENTIFIED AND A SCAR WAS ISSUED TO THE SUPPLIER AS WELL AS PHOTOS OF THE REPORTED MALFUNCTION. A RESPONSE TO THE SCAR HAS BEEN RECEIVED. FROM (B)(6) 2017 TO (B)(6) 2018, DEROYAL HAS SOLD (B)(4) CASES OF THE AFFECTED FINISHED GOOD. EACH CASE CONTAINS (B)(4) EACH, WHICH EQUATES TO A TOTAL OF (B)(4) EACH SOLD. TWO SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS PART NUMBER, WHICH RESULTS IN A COMPLAINT-TO-SALES RATIO OF (B)(4) PERCENT. DEROYAL WILL CONTINUE TO MONITOR POST-MARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF THE ISSUE RECURS. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THIS REPORT IS BEING SUBMITTED OUTSIDE THE 30 DAY REQUIREMENT DUE TO EMPLOYEE OVERSIGHT. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

DURING UNPACKING AND INSPECTION, IT WAS NOTICED THAT FOUR BLADES WERE NOT FULLY RETRACTED. THIS COULD HAVE CAUSED SERIOUS INJURY TO THE PERSON REMOVING THE BLADES.