KNIFE #3 HANDLE MATTE

Additional Manufacturer Narrative

UNIQUE DEVICE INDETIFIER (UDI): (B)(4). KNIFE HANDLE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem

N/A

Additional Manufacturer Narrative

UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). THE RETURNED 110175 HANDLES ARE IN USED CONDITION WITH DAMAGE TO THE ENDS, PREVENTING PROPER BLADE ATTACHMENT. THE REPORTED COMPLAINT IS CONFIRMED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A CUSTOMER REPORTED THAT THE 110175 KNIFE #3 HANDLE MATTE BROKE AND CAUSED MINOR CUTS ON (B)(6) 2020. SHE WAS PUTTING ON THE BLADE WITH A NEEDLE HOLDER ON THE KNIFE HANDLE AND THE BLADE BROKE CAUSING TWO (2) LITTLE MINOR CUTS (LESS THAN 1 CM) ON THE FIRST LAYER OF HER SKIN. IT BLED A LITTLE AND HEALED NICELY.