LEG HOLDER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 2ND FEBRUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER. AS IT WAS STATED, THE TIGHTENING HANDLE OF THE LEG HOLDER GAVE WAY DURING THE INSTALLATION OF THE PATIENT WITHOUT SHOCK OR SIGNIFICANT EFFORT APPLIED. ACCORDING TO PROVIDED INFORMATION, THE ISSUE LED TO A DELAY OF PROCEDURE. TO DATE WE WERE NOT ABLE TO CONFIRM WHETHER PATIENT HAD ALREADY BEEN ANESTHETIZED WHEN THE ISSUE OCCURRED. HOWEVER, AS IT HAS BEEN ASSESSED THAT THIS IS VERY LIKELY, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER USED WITH 100381A0 KNEE CRUTCH, STANDARD. IT WAS REPORTED THAT THE TIGHTENING HANDLE OF THE LEG HOLDER FAILED DURING PATIENT INSTALLATION, DESPITE NO SHOCK OR SIGNIFICANT FORCE BEING APPLIED. THIS ISSUE RESULTED IN A DELAY IN THE PROCEDURE. WHETHER THE PATIENT HAD ALREADY BEEN ANESTHETIZED AT THE TIME OF THE INCIDENT WAS NOT CONFIRMED, IT HAS BEEN ASSESSED THAT THIS IS VERY LIKELY. THEREFORE, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PROCEDURAL DELAY WITH A POTENTIAL OF MAJOR CLINICAL RELEVANCE, WAS TO REOCCUR. THE MALFUNCTION WAS CONFIRMED BY THE ON-SITE SALES MANAGER, THE DEFECTIVE EQUIPMENT WAS REMOVED FROM USE AS A PRECAUTIONARY MEASURE. OPERATING HANDLES (PART NO. 66066263) FOR REPLACEMENT WERE SENT UNDER WARRANTY, AND A TECHNICIAN PROVIDED TRAINING ON THEIR USE. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT AND WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE DEVICE MALFUNCTIONED, IT HAS BEEN ASSESSED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATION. 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 AFFECTED DEVICE WAS MANUFACTURED IN AUGUST 2023 AND HAD BEEN IN USE FOR SIX MONTHS AT THE TIME OF THE INCIDENT. UNFORTUNATELY, A DETAILED EXAMINATION OF THE AFFECTED PART WAS NOT POSSIBLE, AS NO INFORMATION REGARDING THE AVAILABILITY OF THE DAMAGED LEVER WAS PROVIDED BY THE CUSTOMER. GIVEN THE DEVICE'S AGE, A MANUFACTURER ANALYSIS COULD HAVE PROVIDED ADDITIONAL INSIGHTS FOR A ROOT CAUSE INVESTIGATION. ACCORDING TO THE TREND REVIEW, THIS IS THE FIRST REPORTED CASE IN WHICH THE LEVER BROKE DURING TIGHTENING WITHOUT ALLEGEDLY APPLYING EXCESSIVE FORCE. SINCE THERE IS NO CONFIRMATION THAT EXCESSIVE FORCE WAS USED DURING THE ADJUSTMENT, WE CANNOT ATTRIBUTE THE ROOT CAUSE TO USER ERROR. DETAILED INSTRUCTIONS FOR ADJUSTING THE LEG HOLDER CAN BE FOUND IN IFU 1003.80 REV 1, PAGES 17¿18. IN SUMMARY AND AS A RESULT OF THE PERFORMED INVESTIGATION, IT WAS CONCLUDED THAT THE ROOT CAUSE OF THE ISSUE - THE FAILURE OF THE LEG HOLDER'S LOCKING HANDLE - LED TO THE POTENTIAL FOR SERIOUS INJURY, NAMELY THE PROCEDURAL DELAY WITH A POTENTIAL OF MAJOR CLINICAL RELEVANCE, WAS IMPOSSIBLE TO DEFINE. 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) #, H3A DEVICE EVALUATED BY MFG?, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE -EXPLAIN, H4 MANUFACTURE DATE, H6 HEALTH EFFECT ¿ IMPACT CODES, H6 MEDICAL DEVICE ¿ PROBLEM CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED AND THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 2ND FEBRUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER. AS IT WAS STATED, THE TIGHTENING HANDLE OF THE LEG HOLDER GAVE WAY DURING THE INSTALLATION OF THE PATIENT WITHOUT SHOCK OR SIGNIFICANT EFFORT APPLIED. ACCORDING TO PROVIDED INFORMATION, THE ISSUE LED TO A DELAY OF PROCEDURE. TO DATE WE WERE NOT ABLE TO CONFIRM WHETHER PATIENT HAD ALREADY BEEN ANESTHETIZED WHEN THE ISSUE OCCURRED. HOWEVER, AS IT HAS BEEN ASSESSED THAT THIS IS VERY LIKELY, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER USED WITH 100381A0 KNEE CRUTCH, STANDARD. IT WAS REPORTED THAT THE TIGHTENING HANDLE OF THE LEG HOLDER FAILED DURING PATIENT INSTALLATION, DESPITE NO SHOCK OR SIGNIFICANT FORCE BEING APPLIED. THIS ISSUE RESULTED IN A DELAY IN THE PROCEDURE. WHETHER THE PATIENT HAD ALREADY BEEN ANESTHETIZED AT THE TIME OF THE INCIDENT WAS NOT CONFIRMED, IT HAS BEEN ASSESSED THAT THIS IS VERY LIKELY. THEREFORE, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PROCEDURAL DELAY WITH A POTENTIAL OF MAJOR CLINICAL RELEVANCE, WAS TO REOCCUR. THE MALFUNCTION WAS CONFIRMED BY THE ON-SITE SALES MANAGER, THE DEFECTIVE EQUIPMENT WAS REMOVED FROM USE AS A PRECAUTIONARY MEASURE. OPERATING HANDLES (PART NO. 66066263) FOR REPLACEMENT WERE SENT UNDER WARRANTY, AND A TECHNICIAN PROVIDED TRAINING ON THEIR USE. PREVIOUS D4 CATALOG #:100380A0. 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 MFG?: NO. CORRECTED H3A DEVICE EVALUATED BY MFG?: 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 DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H4 DEVICE MANUFACTURE DATE: 9/1/2023. CORRECTED H4 DEVICE MANUFACTURE DATE: 08/22/2023. PREVIOUS H6 HEALTH EFFECT ¿ IMPACT CODES: SURGICAL INTERVENTION/PROLONGED SURGERY//4632. CORRECTED H6 HEALTH EFFECT ¿ IMPACT CODES: DELAY TO TREATMENT/ THERAPY///4604. PREVIOUS H6 MEDICAL DEVICE ¿ MECHANICAL PROBLEM/UNINTENDED MOVEMENT//3026. CORRECTED H6 MEDICAL DEVICE ¿ MATERIAL INTEGRITY PROBLEM/BREAK//1069.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER USED WITH 100381A0 KNEE CRUTCH, STANDARD. IT WAS REPORTED THAT THE TIGHTENING HANDLE OF THE LEG HOLDER FAILED DURING PATIENT INSTALLATION, DESPITE NO SHOCK OR SIGNIFICANT FORCE BEING APPLIED. THIS ISSUE RESULTED IN A DELAY IN THE PROCEDURE. WHETHER THE PATIENT HAD ALREADY BEEN ANESTHETIZED AT THE TIME OF THE INCIDENT WAS NOT CONFIRMED, IT HAS BEEN ASSESSED THAT THIS IS VERY LIKELY. THEREFORE, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PROCEDURAL DELAY WITH A POTENTIAL OF MAJOR CLINICAL RELEVANCE, WAS TO REOCCUR.