RIGIDFIX 210133Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10886705000890), received between Dec 19, 2017 and Jul 8, 2026 — classified as 6 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (45 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047136 ↗
• MalfunctionDec 28, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RGDFX CRVE ST ACL PLA XPIN SYS ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE PHYSICIAN CHANGED ANOTHER THREE RIGIDFIX FEM 3.3MM S/T XPIN ANCHORS TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 4 OF 4 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031615 ↗
• MalfunctionDec 28, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RGDFX CRVE ST ACL PLA XPIN SYS ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE PHYSICIAN CHANGED ANOTHER THREE RIGIDFIX FEM 3.3MM S/T XPIN ANCHORS TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 4 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031614 ↗
• MalfunctionDec 28, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RGDFX CRVE ST ACL PLA XPIN SYS ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE PHYSICIAN CHANGED ANOTHER THREE RIGIDFIX FEM 3.3MM S/T XPIN ANCHORS TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 4 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031613 ↗
• MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE SCREW FELL OFF. 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 20639273 ↗
• MalfunctionAug 5, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE TIP WAS JAMMED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907645 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE BROKE OFF, THEN ALL THE BROKEN PARTS WERE REMOVED. 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 19731367 ↗
• MalfunctionJul 2, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TWO (X2) RIGIDFIX FEM 3.3MM S/T XPIN DEVICES COLD WELDED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655966 ↗
• MalfunctionJul 2, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TWO (X2) RIGIDFIX FEM 3.3MM S/T XPIN DEVICES COLD WELDED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655696 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE BROKE THEN REMOVED ALL THE BROKEN PARTS. 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 19567846 ↗
• MalfunctionMar 20, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM ITALY THAT DURING AN UNKNOWN SURGICAL PROCEDURE IT WAS OBSERVED THAT DURING DRILLING ALONG THE FEMORAL GUIDE, IT WAS OBSERVED THAT THE SLEEVE OF THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE MELTED WITH THE TROCAR. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ANOTHER LIKE DEVICE WAS USED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941115 ↗
• MalfunctionMar 20, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM ITALY THAT DURING AN UNKNOWN SURGICAL PROCEDURE IT WAS OBSERVED THAT DURING DRILLING ALONG THE FEMORAL GUIDE, IT WAS OBSERVED THAT THE SLEEVE OF THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE MELTED WITH THE TROCAR. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ANOTHER LIKE DEVICE WAS USED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941026 ↗
• MalfunctionFeb 28, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE WAS FOUND TO BE BENT AND BREAKAGE. 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 18795905 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRIA THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A RIGIDFIX FEM 3.3MM S/T XPIN WAS USED. ACCORDING TO THE REPORT, POSTOPERATIVELY ON AN UNKNOWN DATE, THE PATIENT RE-RUPTURED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16640060 ↗
• MalfunctionMar 10, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SLEEVE ON THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE WAS COLD WELDED TO THE TROCAR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13723945 ↗
• MalfunctionMar 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER IN (B)(4) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT IT WAS DIFFICULT TO INSERT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE INTO THE GUIDE AND SO IT GOT STUCK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SLEEVE AND THE TROCAR WERE FOUND JAMMED. THE PROCEDURE WAS COMPETED WITH AN UNSPECIFIED DELAY. 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 13685530 ↗
• MalfunctionSep 28, 2021Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT IT WAS DIFFICULT TO INSERT THE CUTTER INTO THE RIGIDFIX FEM 3.3MM S/T XPIN GUIDE DEVICE THAT IT GOT STUCK. THERE WAS AN UNSPECIFIED DELAY TO COMPLETE THE PROCEDURE. 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 12542633 ↗
• MalfunctionAug 19, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE COLD WELDED TO SLEEVE UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341718 ↗