RIGIDFIX 213702Recalls & reported problems
Medos International Sàrl · RIGIDFIX FEMORAL BTB GUIDE FRAME · Class 1
All models of RIGIDFIX (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This RIGIDFIX femoral guide frame is a surgical tool used during knee ligament surgery. The 24 reports mostly describe parts of the frame or related screws breaking during use, sometimes jamming or leaving small fragments that were removed, with procedures completed. The reports mention no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886705002962), received between Jul 16, 2018 and Apr 20, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Break” (21 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break21
- Device-Device Incompatibility2
- Mechanical Jam2
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient12
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE OF THE KNEE IT WAS OBSERVED THAT THE RIGIDFIX FEM GDEFR B/T/B SCREW DEVICE BROKE WHILE UNSCREWING DURING REMOVAL. IT WAS REPORTED THAT FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931686 ↗MalfunctionFeb 26, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE RIGIDFIX FEMROD 10MM *EA DEVICE BROKE WHILE BEING USED TOGETHER WITH THE RIGIDFIX FEM GDEFR B/T/B DEVICE. THE REPORTER CLARIFIED THAT THE RIGIDFIX FEM GDEFR B/T/B DEVICE COULD NOT BE REMOVED AS A RESULT OF THIS EVENT. THE REPORTER ALSO STATED THAT THE DEVICE ITSELF DID NOT HAVE ANY ISSUES. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES) : DEVICE FRACTURED. THE SURGICAL PROCEDURE WAS DELAYED FOR A FEW MINUTES TO OBTAIN A REPLACEMENT DEVICE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470355 ↗MalfunctionDec 30, 2024Use of Device Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Use of Device Problem; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE THE RIGIDFIX FEM GDEFR B/T/B DEVICE BROKE OFF AND IT IS UNABLE TO BE TIGHTENED OR LOOSENED. IT IS UNKNOWN WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21034707 ↗MalfunctionOct 29, 2024Break; Break
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE SCREW THAT FASTENED THE PLATES TOGETHER ON THE RIGIDFIX FEMORAL BTB GUIDE FRAME DEVICE BROKE IN HALF (SCREW TOP SEPARATED FROM THREADS). ACCORDING TO THE REPORT, THIS HAPPENED WHILE THE SCRUB TECH WAS SETTING UP THE GUIDE AWAY FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559861 ↗MalfunctionDec 20, 2023Break; Break
IT WAS REPORTED FROM ITALY THAT THE RIGIDFIX FEM GDEFR B/T/B *EA DEVICE RUPTURED. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18364783 ↗MalfunctionDec 7, 2023Break; Break
IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL REPAIR PROCEDURE ON (B)(6) 2023, A PIECE OF THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18281318 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE NUT ON THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK DEVICE BROKE OFF AND UNABLE TO BE UNSCREWED WHILE THE RIGIDFIX FEM ROD, 10.5MM DEVICE WAS STILL IN THE FRAME AND COULD NOT BE TAKEN OUT WHILE ENTERING THE FEMORAL TUNNEL. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973027 ↗MalfunctionMay 3, 2023Break; Break
IT WAS REPORTED BY THE SALES REP IN ITALY THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S DEVICE WAS PHYSICALLY BROKEN. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16862487 ↗MalfunctionApr 17, 2023Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT THERE WAS RUPTURE OF THE RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW INTO THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S DEVICE WHILE IN USE TOGETHER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16756015 ↗MalfunctionMar 8, 2023Break; Break
IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SCREW ON THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S SNAPPED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16505639 ↗MalfunctionFeb 3, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE SALES REP THAT THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK DEVICE WAS STICKY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11274164 ↗MalfunctionJan 11, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK AND THE RIGIDFIX FEMORAL ROD 11 MM BTB 1PK BROKE AND GOT STUCK TOGETHER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11149115 ↗MalfunctionNov 5, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK AND THE RIGIDFIX FEM ROD, 9.5MM GOT STUCK TOGETHER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10796289 ↗MalfunctionOct 19, 2020Break; Break
IT WAS REPORTED BY THE AFFILIATE THE SCREW BROKE OFF THE BTB GUIDE 213702, WHICH MEANS THEY ARE UNABLE TO REMOVE 10MM FEMORAL GUIDE ROD 213710. THIS DID NOT HAPPEN DURING THE OPERATION, AND NO PATIENT WAS IMPACTED IN ANY WAY. THIS OCCURRED DURING THE CLEANING OF THE INSTRUMENT PRIOR TO STERILIZING. THIS INSTRUMENT HAS ALREADY BEEN RETURNED TO JNJ (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10696639 ↗MalfunctionAug 24, 2020Break; Break
IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THE RIGIDFIX FEM GDEFR B/T/B EA. THE LOCKING THUMB SCREW HAS BROKEN (THE ISSUE IS THE THUMB SCREW, THE REST OF THE INSTRUMENT IS IN WORKING ORDER) THE ONLY THING REQUIRING REPLACEMENT IS THE THUMB SCREW SURGEON WAS USING THE DEVICE WHEN HE WENT TO UNDO THE THUMB SCREW IT BROKEN. NO HARM OR ISSUE OCCURRED TO THE PATIENT AS THE JIG WAS FINISHED BEING USED. NO SURGICAL DELAY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10445536 ↗MalfunctionAug 24, 2020Break; Break
IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THE RIGIDFIX FEM GDEFR B/T/B EA. THE LOCKING THUMB SCREW HAS BROKEN (THE ISSUE IS THE THUMB SCREW, THE REST OF THE INSTRUMENT IS IN WORKING ORDER) THE ONLY THING REQUIRING REPLACEMENT IS THE THUMB SCREW SURGEON WAS USING THE DEVICE WHEN HE WENT TO UNDO THE THUMB SCREW IT BROKEN. NO HARM OR ISSUE OCCURRED TO THE PATIENT AS THE JIG WAS FINISHED BEING USED. NO SURGICAL DELAY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10444702 ↗MalfunctionAug 24, 2020Break; Break
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT AFTER AN ACL PROCEDURE THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK AND THE RIGIDFIX FEMORAL ROD 10 MM 1PK GOT STUCK TOGETHER. IT LOOKS LIKE THE SCREW BROKE UP AND GOT STUCK IN THE GUIDE. NO PATIENT CONSEQUENCES OR PROCEDURE DELAY REPORTED AS THE CASE WAS ALREADY COMPLETED. THESE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10443073 ↗MalfunctionSep 13, 2019Break; Break
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT POST TO AN UNKNOWN PROCEDURE PART OF THE THUMB SCREW ON THE CUSTOMER'S RIGIDFIX FEMORAL BTB GUIDE FRAME IS BROKEN OFF IN THE GUIDE. THE ISSUE WAS FOUND AFTER THE CASE WAS COMPLETED WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9039668 ↗MalfunctionJan 14, 2019Break; Break
THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THUMB SCREW ON THEIR RIGIDFIX FEMORAL BTB GUIDE FRAME BROKE AND THEIR RIGIDFIX FEMORAL ROD 9MM WAS STUCK IN THE GUIDE FRAME. THE SALES REP STATED THAT WHERE THE DEVICE BROKE WAS OUTSIDE THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON HAD COMPLETED THE PROCEDURE WITH THE DEVICE BEFORE THE DEVICE FAILURE OCCURRED. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES OR DELAYS IN THE CASE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE GUIDE FRAME WAS LESS THAN A YEAR OLD AND THE ROD WAS APPROXIMATELY FOUR YEARS OLD, BOTH DEVICES HAVE SEEN HEAVY USE IN THE FIELD. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8245762 ↗MalfunctionDec 27, 2018Break; Break
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT POST TO AN ACL PROCEDURE THE THUMB SCREW ON THE CUSTOMER'S RIGIDFIX FEMORAL BTB GUIDE FRAME BROKE OFF AND THEY WERE UNABLE TO REMOVE THE ROD FROM INSIDE OF THE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE THUMBSCREW WAS BROKEN. THE SALES REP CONFIRMED THAT NOTHING FELL OR BROKE IN THE PATIENT. THE PROCEDURE HAD BEEN COMPLETED WITH THE DEVICE PRIOR TO THE ISSUE OCCURRING WITH NO PATIENT HARM OR DELAYS TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS OVER FIVE YEARS OLD AND HAS SEEN HEAVY USE IN THE FIELD. THE DEVICE WILL BE RETURNING FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8199068 ↗MalfunctionNov 15, 2018Break; Break
IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE, IT WAS OBSERVED THAT THER RIGIDFIX THUMBSCREW DEVICE BROKE WHILE IN USE WITH THE 0MM RIGIDFIX FEMORAL ROD DEVICE. THEY OPENED ANOTHER TRAY TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8074285 ↗MalfunctionAug 16, 2018Break; Break
THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT AT THE END OF AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THUMBSCREW ON THE CUSTOMER RIGIDFIX BTB GUIDEFRAME BROKE OFF CAUSING THEIR FEMORAL ROD, 10MM TO BECOME STUCK INSIDE THE GUIDEFRAME. THE HAPPENED AT THE END OF THE PROCEDURE WHEN THE DEVICE WAS BEING REMOVED. THE SALES REP REPORTED THAT THE SURGEON HAD COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7788402 ↗MalfunctionAug 8, 2018Break; Break
THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE CUSTOMER THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR, IT WAS OBSERVED THAT THE SURGEON BROKE THE SLEEVE AND THE RIGIDFIX CROSS PIN WHILE IN USE TOGETHER OUTSIDE THE PATIENT DUE TO EXCESSIVE FORCE WITH THE PATIENT BEING A YOUNGER FEMALE WITH HARD BONE MATTER. IT WAS REPORTED THAT THE SURGEON USED EXCESSIVE FORCE, AS THE PATIENT WAS A YOUNG FEMALE WITH HARD BONES. THE SURGEON USED ANOTHER LIKE KIT TO COMPLETE THE PROCEDURE WITH A 10 MINUTE DELAY AND NO PATIENT CONSEQUENCES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7761534 ↗MalfunctionJul 16, 2018Break; Break
IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL REPAIR THAT THE PIN ON THE CUSTOMER'S RIGIDFIX GUIDE FRAME BROKE AS THE SURGEON WAS MALLETING THE FRAME UP. THE SALES REP REPORTED THAT THIS CAUSED THE FEMORAL ROD 10MM TO BECOME STUCK INSIDE THE GUIDE FRAME. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP COULD NOT PROVIDE THE LOT NUMBERS BUT STATED THE DEVICES WERE OVER 4 YEARS OLD. THE DEVICES WERE DISCARDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7690083 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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