RIGIDFIXRecalls & reported problems across all models

We found 19 models of RIGIDFIX by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 251 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2017 and Jul 8, 2026 — classified as 19 injuries, 232 malfunctions.

The most frequently reported specific device problem is “Break” (116 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RIGIDFIX problems

RIGIDFIX models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RIGIDFIX 210133

  PIN, FIXATION, SMOOTH
  91 reports
• RIGIDFIX 213701

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  30 reports
• RIGIDFIX 210127

  PIN, FIXATION, SMOOTH
  28 reports
• RIGIDFIX 213702

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  24 reports
• RIGIDFIX 213013

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  15 reports
• RIGIDFIX 213600

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  13 reports
• RIGIDFIX 213709

  Guide, surgical, instrument
  11 reports
• RIGIDFIX 213710

  Guide, surgical, instrument
  10 reports
• RIGIDFIX 213706

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  5 reports
• RIGIDFIX 213708

  Guide, surgical, instrument
  4 reports
• RIGIDFIX 213711

  Guide, surgical, instrument
  4 reports
• RIGIDFIX 213703

  ACCESSORIES,ARTHROSCOPIC
  3 reports
• RIGIDFIX 213705

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• RIGIDFIX 213719

  Guide, surgical, instrument
  3 reports
• RIGIDFIX 213718

  Guide, surgical, instrument
  2 reports
• RIGIDFIX 213004

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  2 reports
• RIGIDFIX 213704

  APPLIER, STAPLE, SURGICAL,
  1 report
• RIGIDFIX 213717

  Guide, surgical, instrument
  1 report
• RIGIDFIX 213027

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 report

Recent RIGIDFIX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE WAS JAMMED/SEIZED. IT WAS INITIALLY REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DRILL DID NOT CORRESPOND TO THE SLEEVE ON THE RIGHT SIDE. THERE WERE NO DELAYS TO THE SURGERY. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 25752302 ↗
• MalfunctionJun 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE WAS JAMMED/SEIZED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A MATCH ISSUE. THE DISPOSABLE DRILL AND SLEEVE DID NOT FIT AND COULD NOT BE USED DURING A SURGICAL PROCEDURE. THE LEFT SIDE WAS THE AFFECTED SIDE. THERE WAS NO DELAY TO THE PROCEDURE. 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 25537989 ↗
• MalfunctionMay 5, 2026Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT OF THE KNEE JOINT PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE RGDFX CRVE ST ACL PLA XPIN SYS DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS FURTHER REPORTED THAT THE SCREW ON THE MILAGRO ADVANCE SCREW 7X30MM DEVICE ALSO BROKE OFF. ALL THE PIECES WERE REMOVED FROM THE PATIENT. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 25085091 ↗
• 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 ↗
• MalfunctionApr 13, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PINS ON THE SIDE OF THE DRILL BIT FOR THE FERRULES BROKE OFF FOR (2) RGDFX CRVE ST ACL PLA XPIN SYS DEVICES. IT WAS REPORTED THAT TWO KITS WITH THE SAME LOT NUMBER WERE USED. THE FIRST DRILL BIT WAS COMPLETELY STUCK IN THE FERRULE AND WOULDN'T COME OUT AFTERWARD. WHEN THE DRILL WAS RETRIEVED, THE FERRULE CAME OUT WITH IT. IT TURNED OUT THAT THE PINS HAD BROKEN OFF THE DRILL BIT. THE SECOND KIT USED A NEW FERRULE, WHICH WAS EXTRA WET. THIS ONE WAS DRILLED PROPERLY, AND THE TIPS WERE CHECKED; THEY WERE STILL THERE. WHEN DRILLING THE SECOND FERRULE, IT DIDN'T GO ALL THE WAY IN. IT THEN TURNED OUT THAT THE PINS HAD BROKEN OFF THERE AS WELL. THE REMNANTS OF THE TIPS STILL HAD A LITTLE BIT OF GRIP, BUT THAT QUICKLY DISAPPEARED. THE FERRULE WAS HAMMERED IN THE REST OF THE WAY (THERE WASN'T A THIRD KIT AVAILABLE).THE CROSS PINS WENT IN WITHOUT ANY PROBLEMS, AND THE CRUCIATE LIGAMENT WAS ALSO SECURED PROPERLY. IT WAS FURTHER REPORTED THAT THE KIT BOXES WERE RETAINED, BUT UNFORTUNATELY NOT THE DRILL BITS THEMSELVES. IT WAS REPORTED THAT DUE TO THE EVENT, THE SURGERY WAS PROLONGED BY 15-20 MINUTES. ALL AVAILABLE INFORMATION HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858145 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PINS ON THE SIDE OF THE DRILL BIT FOR THE FERRULES BROKE OFF FOR (2) RGDFX CRVE ST ACL PLA XPIN SYS DEVICES. IT WAS REPORTED THAT TWO KITS WITH THE SAME LOT NUMBER WERE USED. THE FIRST DRILL BIT WAS COMPLETELY STUCK IN THE FERRULE AND WOULDN'T COME OUT AFTERWARD. WHEN THE DRILL WAS RETRIEVED, THE FERRULE CAME OUT WITH IT. IT TURNED OUT THAT THE PINS HAD BROKEN OFF THE DRILL BIT. THE SECOND KIT USED A NEW FERRULE, WHICH WAS EXTRA WET. THIS ONE WAS DRILLED PROPERLY, AND THE TIPS WERE CHECKED; THEY WERE STILL THERE. WHEN DRILLING THE SECOND FERRULE, IT DIDN'T GO ALL THE WAY IN. IT THEN TURNED OUT THAT THE PINS HAD BROKEN OFF THERE AS WELL. THE REMNANTS OF THE TIPS STILL HAD A LITTLE BIT OF GRIP, BUT THAT QUICKLY DISAPPEARED. THE FERRULE WAS HAMMERED IN THE REST OF THE WAY (THERE WASN'T A THIRD KIT AVAILABLE).THE CROSS PINS WENT IN WITHOUT ANY PROBLEMS, AND THE CRUCIATE LIGAMENT WAS ALSO SECURED PROPERLY. IT WAS FURTHER REPORTED THAT THE KIT BOXES WERE RETAINED, BUT UNFORTUNATELY NOT THE DRILL BITS THEMSELVES. IT WAS REPORTED THAT DUE TO THE EVENT, THE SURGERY WAS PROLONGED BY 15-20 MINUTES. ALL AVAILABLE INFORMATION HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858144 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON P BR DS ANCHOR W/OC ANCHOR DEVICE, THE RGDFX CRVE ST ACL PLA XPIN SYS DEVICE AND THE MILAGRO ADVANCE SCREW 8X23MM DEVICE WERE BROKEN. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. SPARE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273572 ↗
• MalfunctionFeb 4, 2026Break

  THIS IS EVENT 4 OF 4 OF (B)(4). IT WAS REPORTED THAT DURING A JOINT SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X MILAGRO ADVANCE SCREW DEVICES AND 2X RIGIDFIX FEM 3.3MM S/T XPIN DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261196 ↗
• MalfunctionFeb 4, 2026Break

  THIS IS EVENT 3 OF 4 OF (B)(4). IT WAS REPORTED THAT DURING A JOINT SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X MILAGRO ADVANCE SCREW DEVICES AND 2X RIGIDFIX FEM 3.3MM S/T XPIN DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261148 ↗
• MalfunctionJan 6, 2026Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A KNEE SURGERY, IT WAS DISCOVERED THAT THE ANCHOR ON THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. FURTHERMORE, THE NEEDLE ON THE 5.5 HEALIX ADVANCE KNTLSS BR ALSO BROKE OFF. ANOTHER ANCHOR AND NEEDLE WERE USED TO COMPLETE THE SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 23977558 ↗
• MalfunctionJan 5, 2026Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958613 ↗
• MalfunctionJan 5, 2026Break

  THIS IS REPORT 2 OF 2 OF PC-(B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958612 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT DURING POST SURGERY FOR AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE RIGIDFIX FEM GDEFR S/T *EA DEVICE WAS IN THE FEMORAL TUNNEL, THE KNOB THAT WAS USED TO FIXATE THE 10MM ROD INTO THE NEW FRONT GUIDE WAS BROKEN OFF. IT WAS REPORTED THAT THE CASE WAS COMPLETED USING RIGID FIX SOFT TISSUE GUIDE AND ROD HOWEVER WERE UNABLE TO GET THE ROD OUT BECAUSE THE SCREW WAS BROKEN OFF IN IT AND IT DID NOT FLUSH AND COULD NOT GET THE SCREW OUT. 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 23412413 ↗
• MalfunctionSep 18, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A LEFT ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN ANCHOR DEVICE WAS COLD WELDING. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089300 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE SLEEVE ASSEMBLY WAS BROKEN WHILE IN USE. ACCORDING TO THE REPORTER THE PIN WAS EMBEDDED, DIFFICULT TO REMOVE AND APPROXIMATELY 1.5 CM OF METAL WAS LEFT IN SITU. IT WAS REPORTED THAT THE PIN WAS EMBEDDED AND THERE SHOULD NOT BE ANY PROBLEMS WITH IT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22506423 ↗

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