RIGIDFIX 213708Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705003020), received between Jul 17, 2018 and Aug 8, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL ROD 8 MM ST 1PK DEVICE DID NOT FIT INTO THE GUIDE. THERE WAS A SMALL DELAY TO ATTACH ROD TO THE GUIDE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15187119 ↗
• MalfunctionJan 22, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL RECONSTRUCTION SURGICAL PROCEDURE, AFTER REMOVING THE SOFT TISSUE U-SHAPED GUIDE FROM THE PATIENT'S KNEE, THE TECH IN THE BACK TABLE TRIED TO UNSCREW THE 8MM ROD FROM THE SOFT TISSUE GUIDE AND THE BOLT THAT HOLDS BOTH GUIDES TOGETHER BROKE OFF; LEAVING THE 8MM GUIDE ATTACHED TO THE SOFT TISSUE GUIDE. TOURNIQUET TIME WAS NOT AFFECTED FROM THE NORM. THE GUIDE WAS NO LONGER NEEDED DURING THAT CASE. 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 8266721 ↗
• MalfunctionNov 26, 2018Mechanical Jam; Mechanical Jam

  THE SALES REPRESENTATIVE REPORTED THAT THE CUSTOMERS RIGIDFIX FEMORAL RODD 8MM IS WORN AT THE TIP AREA, AND THE 7MM RIGIDFIX FEMORAL ROD WAS WARPED AT THE TIP. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING OTHER LIKE DEVICES, WITH NO DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102424 ↗
• MalfunctionJul 17, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY SALES REPRESENTATIVE THAT THE SURGEON USED A RIGIDFIX FEMORAL ST GUIDE FRAME, WITH AN 8MM ST FEMORAL ROD, ON A PATIENT IN AN ACL PROCEDURE. AFTER THE SURGEON WAS FINISHED USING THE DEVICE IN THE PROCEDURE, THE CUSTOMER WAS HAVING SOME DIFFICULTY TRYING TO UNSCREW THE THUMBSCREW ON THE DEVICE WHEN THE THUMBSCREW BROKE OFF, PREVENTING THE FEMORAL ROD FROM BEING REMOVED FROM THE GUIDE FRAME. POST USE, NO PATIENT CONSEQUENCES. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51369.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693882 ↗