SAFETYSCALPEL ASMBD #3 FITMENT, #11 BLADE, BLUE NS

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "PROTRUDING BLADES ON NON RETRACTED SCALPELS CAUSED INJURY TO AN OPERATOR, OPERATOR WAS WEARING PROTECTIVE GLOVES AND THE BLADE PIERCED THE GLOVES." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE BUT IT WAS NOT AVAILABLE. DEROYAL INDUSTRIES REVIEWED THE PURCHASE ORDER ASSOCIATED WITH THE LOT NUMBER PROVIDED AND NO ISSUES WERE FOUND. DEROYAL DOES NOT MANUFACTURE THE PRODUCT BUT RECEIVES THE SCALPELS ALREADY BOXED AND PLACES AN OUTER LABEL ONTO THE BOX WHICH INCLUDES A WARNING THAT STATES : WARNING: DO NOT REACH HAND INTO BOX. BLADES MAY BECOMES EXPOSED DURING SHIPMENT. NO INVENTORY CHECK WAS ABLE TO BE PERFORMED BY DEROYAL AS NO INVENTORY WAS ON HAND. BECAUSE DEROYAL DOES NOT OWN THE SPECIFICATIONS FOR THIS PRODUCT, NO RISK ANALYSIS WAS AVAILABLE FOR REVIEW. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM MARCH 2023 TO MARCH 2025 AND FOUND TO BE (B)(4)%. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, S & S SURGICAL. THIS WAS INCORRECTLY LISTED BEFORE AND HAS BEEN CORRECTED. THE SUPPLIER REVIEWED THE ASSEMBLY PROCESS AND INVENTORY ON HAND AND NO ISSUES WERE FOUND. AN SAMPLE LOT WAS ASSEMBLED AND TESTED AND ALL SAMPLES FUNCTIONED AS DESIGNED WITH NO ISSUES. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT RETURNED AND NO ISSUES COULD BE FOUND WITHIN THE ASSEMBLY OR MANUFACTURING PROCESS, NO ROOT CAUSE WAS ABLE TO BE DETERMINED. POTENTIAL ROOT CAUSE: BECAUSE NO ISSUES WERE ABLE TO BE FOUND IN THE ASSEMBLY AND MANUFACTURING PROCESSES, IT IS A POTENTIAL THAT THIS ISSUES OCCURRED WITHIN SHIPPING IN THE BULK PACKAGE. CORRECTIVE AND PREVENTIVE ACTIONS: NO MANUFACTURING ACTIONS WERE TAKEN, BUT SUPPLIER STATED THAT BULK PACKAGING IS BEING REVISED TO CORRECT AND ELIMINATE ISSUE IN TRANSIT. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "PROTRUDING BLADES ON NON RETRACTED SCALPELS CAUSED INJURY TO AN OPERATOR, OPERATOR WAS WEARING PROTECTIVE GLOVES AND THE BLADE PIERCED THE GLOVES." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE BUT IT WAS NOT AVAILABLE. DEROYAL INDUSTRIES REVIEWED THE PURCHASE ORDER ASSOCIATED WITH THE LOT NUMBER PROVIDED AND NO ISSUES WERE FOUND. DEROYAL DOES NOT MANUFACTURE THE PRODUCT BUT RECEIVES THE SCALPELS ALREADY BOXED AND PLACES AN OUTER LABEL ONTO THE BOX WHICH INCLUDES A WARNING THAT STATES: WARNING: DO NOT REACH HAND INTO BOX. BLADES MAY BECOMES EXPOSED DURING SHIPMENT. NO INVENTORY CHECK WAS ABLE TO BE PERFORMED BY DEROYAL AS NO INVENTORY WAS ON HAND. BECAUSE DEROYAL DOES NOT OWN THE SPECIFICATIONS FOR THIS PRODUCT, NO RISK ANALYSIS WAS AVAILABLE FOR REVIEW. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM MARCH 2023 TO MARCH 2025 AND FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, (B)(4). THE SUPPLIER REVIEWED THE ASSEMBLY PROCESS AND INVENTORY ON HAND AND NO ISSUES WERE FOUND. AN SAMPLE LOT WAS ASSEMBLED AND TESTED AND ALL SAMPLES FUNCTIONED AS DESIGNED WITH NO ISSUES. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT RETURNED AND NO ISSUES COULD BE FOUND WITHIN THE ASSEMBLY OR MANUFACTURING PROCESS, NO ROOT CAUSE WAS ABLE TO BE DETERMINED. POTENTIAL ROOT CAUSE: BECAUSE NO ISSUES WERE ABLE TO BE FOUND IN THE ASSEMBLY AND MANUFACTURING PROCESSES, IT IS A POTENTIAL THAT THIS ISSUES OCCURRED WITHIN SHIPPING IN THE BULK PACKAGE. CORRECTIVE AND PREVENTIVE ACTIONS: NO MANUFACTURING ACTIONS WERE TAKEN, BUT SUPPLIER STATED THAT BULK PACKAGING IS BEING REVISED TO CORRECT AND ELIMINATE ISSUE IN TRANSIT. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "PROTRUDING BLADES ON NON RETRACTED SCALPELS CAUSED INJURY TO AN OPERATOR, OPERATOR WAS WEARING PROTECTIVE GLOVES AND THE BLADE PIERCED THE GLOVES." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE BUT IT WAS NOT AVAILABLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE SENT TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A DISTRIBUTING FACILITY REPORTED, " PROTRUDING BLADES ON NON RETRACTED SCALPELS CAUSED INJURY TO AN OPERATOR, OPERATOR WAS WEARING PROTECTIVE GLOVES AND THE BLADE PIERCED THE GLOVES."