TRACTION BOOTS, PAIR

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ THE 10018800 TRACTION BOOTS, PAIR. AS IT WAS STATED, A STRAP OF ONE OF THE ADULT TRACTION BOOTS BROKE OFF DURING SURGERY (RIGHT FEMUR RECON NAIL PROCEDURE) WHILE THE USER WAS INCREASING THE TRACTION BAR. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE STRAP BREAKING OFF DURING THE PROCEDURE WHICH COULD POTENTIALLY LEAD TO A CHANGE IN THE POSITION OF THE PATIENT'S LEG, WAS TO REOCCUR. THE AFFECTED TRACTION BOOT WAS REPLACED WITH A NEW ONE. THE AFFECTED TRACTION BOOT WAS RETURNED TO THE MANUFACTURING SITE FOR FURTHER INVESTIGATION. THE EVALUATION OF THE AFFECTED ACCESSORY PERFORMED BY THE PROCESS ASSURANCE DEPARTMENT REVEALED NORMAL SIGNS OF USE AND TORN STRAP OF THE BOOT, WHICH WAS DOCUMENTED BY PHOTOGRAPHIC EVIDENCE. THE EXAMINATION PERFORMED BY PROCESS ASSURANCE CONFIRMED THE MALFUNCTION AND IT COULD NOT BE RULED OUT THAT THE TRACTION BOOT HAS BEEN HANDLED IMPROPERLY OR INCORRECTLY BY THE USER. THE AFFECTED ACCESSORY WAS FORWARDED TO THE SUPPLIER OF THE MATERIAL FOR FURTHER EXAMINATION, WHICH REVEALED THAT THERE WERE NO VISIBLE DEFECTS IN THE MATERIAL COMPOSITION, THUS A MATERIAL DEFECT WAS EXCLUDED. ACCORDING TO THE SUPPLIER STATEMENT, THE STRAP BROKE DUE TO REPEATED USE AND TOO MUCH FORCE. BASED ON THE STATEMENT OF THE PROCESS ASSURANCE DEPARTMENT AND THE SUPPLIER OF THE MATERIAL IT WAS CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS USER ERROR RELATED TO THE IMPROPER HANDLING OF THE TRACTION BOOT. THE IMPROPER OR INCORRECT HANDLING BY THE CUSTOMER MAY BE CAUSED BY SEVERAL FACTORS, FOR EXAMPLE, OVERLOAD OR WRONG CLEANING. IN THE USER MANUAL, THE USER IS WARNED ABOUT THE RISK OF INJURY DUE TO MATERIAL FAILURE AS THE MAXIMUM LOAD THAT MAY BE PLACED ON THE PRODUCT IS 10 KG WHICH CORRESPONDS TO ITS SHARE OF THE LOAD (PROPORTIONAL LOAD OF THE WEIGHT OF THE PATIENT, PLUS THE ADDITIONAL LOAD POSED BY SIDE RAIL ACCESSORIES, MOUNTED ACCESSORIES AND/OR OR PERSONNEL) IMPOSED BY A PATIENT WEIGHING 135 KG (IFU 1001.88 EN 07, PAGE 12). THE IMPROPER HANDLING MAY BE RELATED TO THE WRONG CLEANING AND DISINFECTION PROCEDURE. IMPROPER CLEANING MAY CAUSE PROPERTY DAMAGE AND DEFECTS ON TRACTION BOOT LEATHER THAT EXCLUDE THE ACCESSORY FROM FURTHER USE (IFU 1001.88 EN 07, PAGES 18 AND 20). IN THE USER MANUAL, THE USER CAN FIND ALL NECESSARY INFORMATION ABOUT THIS PROCESS: GENERAL INFORMATION AND SAFETY NOTES REGARDING THIS PROCESS (IFU 1001.88 EN 07, PAGES 16-17), SUITABLE AND FORBIDDEN CLEANING AGENTS AND DISINFECTANTS (IFU 1001.88 EN 07, PAGES 17-18) AND CLEANING AND DISINFECTION PROCEDURE STEP BY STEP (IFU 1001.88 EN 07, PAGE 19). THE USER IS WARNED THAT IF UNSUITABLE CLEANING AGENTS AND DISINFECTANTS ARE USED, THE ANTISTATIC PROPERTY AND ELECTRICAL CONDUCTIVITY OF THE PRODUCT MAY BE LOST, WHICH ARE REQUIRED TO PREVENT ELECTROSTATIC CHARGES AS REQUIRED BY THE STANDARD (IFU 1001.88 EN 07, PAGE 17). MOREOVER, THE USER IS WARNED THAT THE PATIENT MAY BE ENDANGERED AS A RESULT OF INCORRECT USE SO THE USER SHOULD FOLLOW THE INSTRUCTIONS FOR USE FOR ALL ACCESSORIES (IFU 1001.88 EN 07, PAGE 13). WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE MALFUNCTION OF THE STRAP OF THE TRACTION BOOT WAS CONFIRMED, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS NOT UP TO SPECIFICATION. THE TREND REVIEW REVEALED THAT WORLDWIDE THERE WERE 5 SIMILAR COMPLAINTS RELATED TO THIS ISSUE INVESTIGATED HERE WHICH WERE REGISTERED AT DIFFERENT CUSTOMER SITES. (B)(4). IN OUR EVALUATION THE INFORMATION WE CURRENTLY HOLD DOES NOT WARRANT ANY FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, AS OVERALL THE DEVICES APPEAR TO BE PERFORMING CORRECTLY, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A.

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER (B)(4).

Description of Event or Problem

ON 14TH MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 10018800 TRACTION BOOTS, PAIR. AS IT WAS STATED, A STRAP OF ONE OF THE ADULT TRACTION BOOTS BROKE OFF DURING SURGERY (RIGHT FEMUR RECON NAIL PROCEDURE) WHILE USER WAS INCREASING THE TRACTION BAR. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE STRAP BREAKING OFF DURING THE PROCEDURE WHICH COULD POTENTIALLY LEAD TO CHANGE IN THE POSITION OF PATIENT'S LEG, WAS TO REOCCUR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.