TRACTION BOOT, ADULT

Description of Event or Problem

ON (B)(6) 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 10018800 - TRACTION BOOTS, PAIR. AS IT WAS STATED, THE BELT WAS TORN WHILE THE PATIENT'S FOOT WAS BEING FIXED ON THE RIGHT TRACTION BOOT DURING A HIP ARTHROSCOPY SURGERY. THE PATIENT HAD ALREADY BEEN ANESTHETIZED WHEN THE ISSUE OCCURRED. THERE WAS NO INJURY REPORTED, HOWEVER, THE SURGERY WAS POSTPONED TO A LATER DATE. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE FIXATION BELT BREAKING DURING USE WHICH COULD POTENTIALLY LEAD TO A CHANGE IN THE POSITION OF THE PATIENT'S LEG AND RESCHEDULED SURGERY ON THE ALREADY ANESTHETIZED PATIENT, WERE TO REOCCUR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.E1B EVENT SITE NAME: (B)(6). H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

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

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 10018800 - TRACTION BOOTS, PAIR. AS IT WAS STATED, THE BELT WAS TORN WHILE THE PATIENT'S FOOT WAS BEING FIXED ON THE RIGHT TRACTION BOOT DURING A HIP ARTHROSCOPY SURGERY. THE PATIENT HAD ALREADY BEEN ANESTHETIZED WHEN THE ISSUE OCCURRED. THERE WAS NO INJURY REPORTED, HOWEVER, THE SURGERY WAS POSTPONED TO A LATER DATE. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FIXATION BELT BREAKING DURING USE WHICH COULD POTENTIALLY LEAD TO A CHANGE IN THE POSITION OF THE PATIENT'S LEG AND RESCHEDULED SURGERY ON THE ALREADY ANESTHETIZED PATIENT, WERE TO REOCCUR. THE AFFECTED DEVICE WAS INSPECTED BY A GETINGE TECHNICIAN, WHO CONFIRMED THAT THE RIVET ON THE FOOT-FIXING BELT OF THE TRACTION BOOT WAS TORN AND BROKEN. DETAILED PHOTOS OF THE DAMAGED FASTENER WERE TAKEN FOR DOCUMENTATION. THE FAULTY TRACTION BOOT WAS SUBSEQUENTLY REPLACED WITH A NEW ONE UNDER WARRANTY. BASED ON THE ATTACHED PICTURES OF THE DAMAGED DEVICE, THERE ARE NO VISIBLE MATERIAL DEFECTS DESPITE THE DAMAGED RIVET. IT IS LIKELY THAT THE STRAP BROKE DUE TO REPEATED USE AND THE APPLICATION OF EXCESSIVE FORCE DURING POSITIONING. THIS MALFUNCTION WAS REVIEWED WITH THE SUBJECT MATTER EXPERT, WHO CONCLUDED THAT IT WAS MOST LIKELY CAUSED BY THE USER. SPECIFICALLY, EXCESSIVE FORCE APPEARS TO HAVE BEEN APPLIED WHILE SECURING THE PATIENT'S FOOT IN THE TRACTION BOOT. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WERE ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE ISSUE OCCURRED DURING THE SURGERY, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR INCIDENT OCCURRED. THE IMPROPER OR INCORRECT HANDLING BY THE CUSTOMER MAY BE CAUSED BY SEVERAL FACTORS, FOR EXAMPLE, OVERLOAD, WHICH COULD HAVE CONTRIBUTED TO REDUCING THE DEVICE'S LIFESPAN. 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 PERSONNEL) IMPOSED BY A PATIENT WEIGHING 135 KG (IFU 1001.88 EN 07, PAGE 12). THE MAXIMUM PERMISSIBLE TENSILE LOAD OF THE PRODUCT IS 700 N. THIS CORRESPONDS TO A MASS OF APPROXIMATELY 70 KG (IFU 1001.88 EN 07, PAGE 12). 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). IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT BASED ON AVAILABLE INFORMATION THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE FIXATION BELT BREAKING DURING USE WHICH COULD POTENTIALLY LEAD TO A CHANGE IN THE POSITION OF THE PATIENT'S LEG AND RESCHEDULED SURGERY ON THE ALREADY ANESTHETIZED PATIENT, IS RELATED TO THE USER ERROR. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE CORRECTION OF D1 BRAND NAME, D4 CATALOG#, D4 SERIAL#, D4 UNIQUE IDENTIFIER (UDI)#, H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE ¿ EXPLAIN, H6 MEDICAL DEVICE ¿ PROBLEM CODE, H6 COMPONENT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D1 BRAND NAME: TRACTION BOOTS, PAIR. CORRECTED D1 BRAND NAME: TRACTION BOOT, ADULT. PREVIOUS D4 CATALOG#: 10018800. CORRECTED D4 CATALOG#: N/A. PREVIOUS D4 SERIAL#: (B)(6). CORRECTED D4 SERIAL#: (B)(6). PREVIOUS D4 UNIQUE IDENTIFIER (UDI)#: N/A. CORRECTED D4 UNIQUE IDENTIFIER (UDI)#: (B)(4). 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. PREVIOUS H6 MEDICAL DEVICE: PROBLEM CODE: MATERIAL INTEGRITY PROBLEM/MATERIAL SPLIT, CUT OR TORN//4008. ACTIVATION, POSITIONING OR SEPARATION PROBLEM/POSITIONING FAILURE/1158. CORRECTED H6 MEDICAL DEVICE: PROBLEM CODE. MATERIAL INTEGRITY PROBLEM/MATERIAL SPLIT, CUT OR TORN//4008. PREVIOUS H6 COMPONENT CODES: MECHANICAL/BELT//737. CORRECTED H6 COMPONENT CODES: MECHANICAL/FASTENER/RIVET/944. MECHANICAL/FASTENER/TAPE FOR FIXATION/990.