SCREW TENSION DEVICE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : THIRD PARTY SERVICE INSPECTION.

Description of Event or Problem

ON 26TH FEBRUARY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - (B)(6) - SCREW TENSION DEVICE USED WITH 141901JC - EXTENSION DEVICE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, CRACKS IN SCREW FIXING PARTS OF THE HOUSING WERE DISCOVERED. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS PROVIDED. IT HAS BEEN CONFIRMED THAT THE ISSUE OCCURRED DURING HIP JOINT DISPLACEMENT SURGERY ON AN ANESTHETIZED PATIENT. AS IT WAS STATED, THE ACCESSORY DETACHED COMPLETELY LEADING TO SLOW CHANGE IN PATIENT POSITION THAT WAS UNDER STAFF CONTROL. THE ISSUE RESULTED IN A DELAY IN PROCEDURE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO CHANGE IN THE PATIENT POSITION AND DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WERE TO REOCCUR.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 10033700 - SCREW TENSION DEVICE USED WITH 141901JC - EXTENSION DEVICE. AS IT WAS STATED CRACKS IN SCREW-FIXING PARTS OF THE HOUSING WERE DISCOVERED. LATER ON, ADDITIONAL INFORMATION WAS PROVIDED. IT HAS BEEN CONFIRMED THAT THE ISSUE OCCURRED DURING HIP JOINT DISPLACEMENT SURGERY ON AN ANESTHETIZED PATIENT. AS IT WAS STATED, THE ACCESSORY DETACHED COMPLETELY LEADING TO A SLOW CHANGE IN PATIENT POSITION THAT WAS UNDER STAFF CONTROL. THE DEVICE HAD TO BE REPLACED WITH ANOTHER UNIT. THE ISSUE RESULTED IN A DELAY IN THE PROCEDURE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO A CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 10033700 - SCREW TENSION DEVICE USED WITH 141901JC - EXTENSION DEVICE. AS IT WAS STATED CRACKS IN SCREW-FIXING PARTS OF THE HOUSING WERE DISCOVERED. LATER ON, ADDITIONAL INFORMATION WAS PROVIDED. IT HAS BEEN CONFIRMED THAT THE ISSUE OCCURRED DURING HIP JOINT DISPLACEMENT SURGERY ON AN ANESTHETIZED PATIENT. AS IT WAS STATED, THE ACCESSORY DETACHED COMPLETELY LEADING TO A SLOW CHANGE IN PATIENT POSITION THAT WAS UNDER STAFF CONTROL. THE DEVICE HAD TO BE REPLACED WITH ANOTHER UNIT. THE ISSUE RESULTED IN A DELAY IN THE PROCEDURE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO A CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR. ACCORDING TO THE DESCRIPTION OF THE COMPLAINT AND PROVIDED PHOTOGRAPHICAL EVIDENCE, THE DAMAGE IN SCREW FIXING PARTS OF THE HOUSING WERE CONFIRMED. THE AFFECTED ACCESSORY WAS REPAIRED IN THE LOCAL MARKET BY CLIENT ENGINEERS. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. AS THE ISSUE OCCURRED DURING THE PROCEDURE, 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. DURING THE INVESTIGATION, IT WAS CONCLUDED THAT THE DAMAGE WAS MOST PROBABLY CAUSED BY THE USER, AS THE SCREW WAS DRILLED BEYOND THE END STOP. IT APPEARS THAT EXCESSIVE FORCE WAS APPLIED WHILE THE PATIENT WAS BEING POSITIONED. THE IMPROPER OR INCORRECT HANDLING BY THE CUSTOMER COULD BE ATTRIBUTED TO SEVERAL FACTORS, WHICH MAY HAVE CONTRIBUTED TO REDUCING THE DEVICE'S LIFESPAN. THE USER MANUAL PROVIDES DETAILED INSTRUCTIONS ON HOW TO HANDLE THE DEVICE AND OUTLINES THE PROPER ADJUSTMENT PROCEDURE (IFU 1003.37 EN 08, PAGES 15-16). SPECIFICALLY, THE IFU HIGHLIGHTS THE RISK OF INJURY DUE TO MATERIAL FAILURE IF THE SCREW TENSION DEVICE IS ADJUSTED BEYOND THE STOP. IT WARNS THAT THE SCREW TENSION DEVICE CAN BREAK, RESULTING IN THE CANCELLATION OF THE EXTENSION TRACTION OR TRACTION FORCE (IFU 1003.37 EN 08, PAGE 14). ADDITIONAL GUIDANCE IS PROVIDED IN THE IFU, INCLUDING: ADJUST THE TELESCOPIC BAR TO THE LENGTH OF THE PATIENT'S STRETCHED LEG (COARSE TRACTION). BEFORE ATTACHING ADDITIONAL ACCESSORIES, EXTEND THE SCREW TENSION DEVICE SUFFICIENTLY TO ACHIEVE THE DESIRED EXTENSION TRACTION OR TRACTION FORCE. ENSURE THAT THE SCREW TENSION DEVICE IS NOT ADJUSTED BEYOND THE STOP DURING EXTENSION TRACTION OR FINE TRACTION. TO ENSURE THE DEVICE OPERATES CORRECTLY, VISUAL AND FUNCTIONAL INSPECTIONS MUST BE PERFORMED BY A TRAINED PERSON PRIOR TO EACH USE. IF CRACKS OR OTHER DAMAGES ARE IDENTIFIED, THE DEVICE SHOULD BE DISCONTINUED IMMEDIATELY. THE IFU INCLUDES A SUGGESTED CHECKLIST FOR SUCH INSPECTIONS (IFU 1003.37 EN 08, PAGES 21-22). 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 DETACHMENT OF THE ACCESSORY LEADING TO A CHANGE IN THE PATIENT'S POSITION, IS RELATED TO THE DEVICE¿S DAMAGE CAUSED BY 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 B5 DESCRIBE EVENT OR PROBLEM, D4 CATALOG #, D4 SERIAL #, D4 UNIQUE IDENTIFIER (UDI) # DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 26TH FEBRUARY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 10033700 - SCREW TENSION DEVICE USED WITH 141901JC - EXTENSION DEVICE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, CRACKS IN SCREW FIXING PARTS OF THE HOUSING WERE DISCOVERED. ON 25TH MARCH 2024, ADDITIONAL INFORMATION WAS PROVIDED. IT HAS BEEN CONFIRMED THAT THE ISSUE OCCURRED DURING HIP JOINT DISPLACEMENT SURGERY ON AN ANESTHETIZED PATIENT. AS IT WAS STATED, THE ACCESSORY DETACHED COMPLETELY LEADING TO SLOW CHANGE IN PATIENT POSITION THAT WAS UNDER STAFF CONTROL. THE ISSUE RESULTED IN A DELAY IN PROCEDURE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO CHANGE IN THE PATIENT POSITION AND DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WERE TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 10033700 - SCREW TENSION DEVICE USED WITH 141901JC - EXTENSION DEVICE. AS IT WAS STATED CRACKS IN SCREW-FIXING PARTS OF THE HOUSING WERE DISCOVERED. LATER ON, ADDITIONAL INFORMATION WAS PROVIDED. IT HAS BEEN CONFIRMED THAT THE ISSUE OCCURRED DURING HIP JOINT DISPLACEMENT SURGERY ON AN ANESTHETIZED PATIENT. AS IT WAS STATED, THE ACCESSORY DETACHED COMPLETELY LEADING TO A SLOW CHANGE IN PATIENT POSITION THAT WAS UNDER STAFF CONTROL. THE DEVICE HAD TO BE REPLACED WITH ANOTHER UNIT. THE ISSUE RESULTED IN A DELAY IN THE PROCEDURE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO A CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR. PREVIOUS D4 CATALOG #: 10033700, 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).