#11 SAFETY SCALPEL

Additional Manufacturer Narrative

INVESTIGATION IS STILL ONGOING. WILL PROVIDE FOLLOW UP WHEN MORE INFORMATION IS RECEIVED.

Description of Event or Problem

********************************* >> QUALITY ISSUE INFORMATION << ********************************* ----------------------- *** PRODUCT DETAILS *** ----------------------- PRODUCT ID: D4511A - #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, NS. LOT/SERIAL #: (B)(4). QUANTITY: 3 EA. DEROYAL SALES ORDER #: 4156349. ----------------------------- *** QUALITY ISSUE DETAILS *** ----------------------------- DATE OF OCCURRENCE: (B)(6) 2017. WHEN DID QUALITY ISSUE OCCUR? BEFORE USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? NOT APPLICABLE. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE. DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: SCALPELS WERE UNLOCKED WITH BLADE ENGAGED AND EXPOSED. PICTURES PROVIDED. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY VISUAL INSPECTION. HOW WAS THE PRODUCT BEING USED? N/A. WAS IT THE INITIAL USE OF THE PRODUCT? NO. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO. ----------------------- *** OUTCOME DETAILS *** ----------------------- OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? NO. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: N/A.

Additional Manufacturer Narrative

ON DECEMBER 11, 2017, THE QUALITY TEAM RECEIVED PHOTOGRAPHIC DOCUMENTATION AND ADDITIONAL INFORMATION TO ASSIST IN EVALUATION AND ANALYSIS OF THE COMPLAINT. DURING THIS EVALUATION, THE DEVICE HISTORY RECORD WAS REVIEWED FOR ANY DISCREPANCIES THAT MIGHT HAVE OCCURED DURING PRODUCTION LEADING TO THE REPORTED ISSUE; NONE WERE FOUND. CURRENT RAW MATERIAL AND FINISHED GOOD INVENTORY WAS EVALUATED FOR ANY SIMILAR DEFECTS; NO ERRORS OR DEFECTS WERE FOUND. ALTHOUGH NO ISSUES WERE UNCOVERED DURING THIS INVESTIGATION, CORRECTIVE ACTION WAS TAKEN TO HELP CONTROL THE SITUATION IN THE FUTURE. ALL APPLICABLE PERSONNEL HANDLING THE PRODUCT WERE RETRAINED ON PROPER PROCEDURES, SPECIFICALLY ON ENSURING THE OPEN MECHANISM FOR THE SCALPEL IS LOCKED CORRECTLY WHEN PERFORMING INSPECTION. TO ENSURE THESE ACTIONS HAVE BEEN IMPLEMENTED AND ARE EFFECTIVE, THE QUALITY TEAM WILL OBTAIN VERIFICATION AT A LATER TIME. ALL CUSTOMER COMPLAINTS ARE MONITORED THROUGH THE INTERNAL CORRECTIVE AND PREVENTATIVE ACTION SYSTEM FOR REPORTED ISSUES, AND IF FURTHER INVESTIGATION OR ACTION IS DEEMED NECESSARY, STEPS WILL BE TAKEN ACCORDINGLY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP WHEN MORE INFORMATION IS RECEIVED.

Description of Event or Problem

QUALITY ISSUE INFORMATION: PRODUCT DETAILS: PRODUCT ID: D4511A - #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, NS. LOT/SERIAL #: (B)(4). QUANTITY: 3 EA. DEROYAL SALES ORDER #: (B)(4). QUALITY ISSUE DETAILS: DATE OF OCCURRENCE: (B)(6) 2017. WHEN DID QUALITY ISSUE OCCUR? BEFORE USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? NOT APPLICABLE. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE. DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: SCALPELS WERE UNLOCKED WITH BLADE ENGAGED AND EXPOSED. PICTURES PROVIDED. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY VISUAL INSPECTION. HOW WAS THE PRODUCT BEING USED? N/A. WAS IT THE INITIAL USE OF THE PRODUCT? NO. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO. OUTCOME DETAILS: OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? NO. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: N/A.