RIGIDFIX 213709Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705003037), received between Jun 13, 2018 and Dec 11, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL ST GUIDE FRAME N/S 1PK WAS BENT/TORQUED AND THE DRILL SLEEVES AND TROCAR WERE BEING PREVENTED FROM CROSSING THE WINDOW OF THE RIGIDFIX FEMORAL ROD 9 MM 1PK. THE DISTAL SLEEVE EVENTUALLY WENT ACROSS. THE PHYSICIAN TRIED TO REPOSITION THE GUIDE FOR THE PROXIMAL PIN, AFTER REAPPROXIMATING THE GUIDE AT A DIFFERENT ANGLE, AND REDRILLING, THEY WERE ABLE TO GET THE PROXIMAL PIN THROUGH THE FRAME. THE SKIVE MARKS WERE VISIBLE IN THE SLEEVE. 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 18301182 ↗
• MalfunctionDec 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON 11/28/2023, IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL ST GUIDE FRAME N/S 1PK WAS BENT/TORQUED AND THE DRILL SLEEVES AND TROCAR WERE BEING PREVENTED FROM CROSSING THE WINDOW OF THE RIGIDFIX FEMORAL ROD 9 MM 1PK. THE DISTAL SLEEVE EVENTUALLY WENT ACROSS. THE PHYSICIAN TRIED TO REPOSITION THE GUIDE FOR THE PROXIMAL PIN, AFTER REAPPROXIMATING THE GUIDE AT A DIFFERENT ANGLE, AND REDRILLING, THEY WERE ABLE TO GET THE PROXIMAL PIN THROUGH THE FRAME. THE SKIVE MARKS WERE VISIBLE IN THE SLEEVE. 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 18301042 ↗
• MalfunctionMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY AFFILIATE VIA EMAIL, THAT PRE-OPERATIVELY TO AN ACL PROCEDURE, POTENTIAL PROBLEM WAS IDENTIFIED BY HOSPITAL CSD AND AN ALTERNATIVE SET WAS USED. DAMAGED INSTRUMENTS ARE: RIGIDFIX FEMROD 9MM *EA (EXPANDS AND CANNOT FIT INTO GUIDE FRAME), RIGIDFIX FEM B/T/B STEPTROC *EA (THEIR ONE IS BARBED AT THE TIP), RIGIDFIX FEM GDEFR B/T/B *EA (SCREW HAS BEEN CROSS THREADED AND WILL NOT GO INTO GUIDE). DEVICES ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067456 ↗
• MalfunctionSep 23, 2019Device Difficult to Setup or Prepare; Connection Problem

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT PRIOR TO USE ON THE PATIENT DURING AN ACL PROCEDURE, THE SALES REP'S RIGIDFIX FEMORAL ROD 9MM WOULD NOT LATCH INTO PLACE WITH A MATING DEVICE. THE CASE WAS COMPLETED WITH A DIFFERENT SIZED LIKE-DEVICE WITH NO PATIENT HARM OR DELAYS TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THIS DEVICE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS 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 9103959 ↗
• MalfunctionJan 14, 2019Mechanical Jam; Mechanical Jam

  THIS IS REPORT 2 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 8246131 ↗
• MalfunctionNov 9, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING AN ACL REPAIR THAT THE THUMBSCREW BROKE OFF HIS RIGIDFIX ST U GUIDE WHEN THE SURGEON WAS MALLETING THE DEVICE IN. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE 9MM ROD WAS NOT ABLE TO BE REMOVED FROM THE GUIDEFRAME AND WILL BE RETURNED WITH THE COMPLAINT DEVICE. THE SALES REPRESENTATIVE COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICES BUT REPORTED THAT THEY WERE OVER THREE (3) YEARS OLD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054873 ↗
• MalfunctionSep 17, 2018Separation Failure; Separation Failure

  THE SALES REP REPORTED THE THUMBSCREW ON THE CUSTOMER'S RIGIDFIX BTB GUIDE BROKE OFF WHILE THE SURGEON WAS TIGHTENING THE THUMBSCREW TO SECURE THE FEMORAL ROD IN THE GUIDE DURING AN ACL PROCEDURE. THE SURGEON STILL USED THE GUIDE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE THREADS OF THE THUMBSCREW ARE STUCK IN THE GUIDE ALSO MAKING THE ROD STUCK IN THE GUIDE. THE ENTIRE GUIDE WITH THE ROD STUCK IN THE DEVICE ARE COMING BACK FOR EVALUATION. DUE TO THIS, THE ENTIRE GUIDE AND THE ROD WERE REPLACED FOR THE CUSTOMER. THE SALES REP DID NOT HAVE LOT NUMBERS BUT VERIFIED THE DEVICES WERE OVER 4 YEARS OLD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7879942 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE HOSPITAL THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION PROCEDURE; AFTER REAMING INTO THE FEMUR AND TIBIA, A 9MM AIMING GUIDE WAS SCREWED INTO RIGIDFIX U-SHAPED GUIDE. WHILE TIGHTENING THE BOLT ON THE U-SHAPED GUIDE TO THE 9MM AIMING GUIDE, THE BOLT BROKE OFF LEAVING A PIECE OF THE BOLT INSIDE THE U-SHAPED GUIDE CAUSING THE 9MM AIMING GUIDE TO BE STUCK INSIDE THE U-SHAPED GUIDE.-NO ADVERSE EFFECTS OCCURRED NOR ANY EXTENDED PROCEDURE TIME. SECURED THE AIMING GUIDE TO THE OPPOSITE SIDE OF THE U-SHAPED GUIDE WITH ANOTHER BOLT. 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 7751836 ↗
• MalfunctionJul 11, 2018Mechanical Jam; Mechanical Jam

  THE SALES REPRESENTATIVE REPORTED THAT THE CUSTOMER'S SOFT TISSUE RIGIDFIX GUIDE AND 9' RIGIDFIX ROD BECAME STUCK TOGETHER WHEN THE SURGEON WAS PERFORMING AN ACL REPAIR. THE SALES REPRESENTATIVE REPORTED THAT WHEN THE SURGEON WAS UNSCREWING THE THUMBSCREW AT THE END OF THE PROCEDURE THE SCREW BROKE IN HIS HAND. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REPRESENTATIVE COULD NOT PROVIDE THE LOT NUMBER OR AGE OF THE DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677775 ↗
• MalfunctionJun 13, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP THAT "SOFT TISSUE ONLY" WAS ETCHED INTO TWO OF HIS RIGIDFIX FEMORAL ROD 10MM AND TWO OF HIS RIGIDFIX FEMORAL ROD 9MM WHEN THEY ARE IN FACT BTB DEVICES. THERE WAS NO CASE OR PATIENT INVOLVEMENT. THE DEVICES ARE BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596058 ↗
• MalfunctionJun 13, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP THAT "SOFT TISSUE ONLY" WAS ETCHED INTO TWO OF HIS RIGIDFIX FEMORAL ROD 10MM AND TWO OF HIS RIGIDFIX FEMORAL ROD 9MM WHEN THEY ARE IN FACT BTB DEVICES. THERE WAS NO CASE OR PATIENT INVOLVEMENT. THE DEVICES ARE BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596051 ↗