RIGIDFIX 213710Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705003044), received between Jun 13, 2018 and Jan 14, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE RIGIDFIX FEMROD 10MM *EA DEVICE BROKE. 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 21150662 ↗
• MalfunctionJul 12, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX FEMROD 10MM DEVICE AND THE RIGIDFIX FEM GDEFR S/T DEVICE WERE STUCK TOGETHER; AND THEREFORE, COULD NOT BE USED. 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 19730537 ↗
• MalfunctionDec 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE IN NEW ZEALAND THAT POSTOPERATIVELY AN UNKNOWN SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT THE RIGIDFIX FEMROD 10MM *EA DEVICE COULD NOT BE REMOVED/DISASSEMBLED FROM THE RIGIDFIX GUIDE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS JAMMED INSIDE OF THE RIGIDFIX GUIDE AND IT WAS UNABLE TO DISASSEMBLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056614 ↗
• MalfunctionNov 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: I WAS NOTIFIED BY THE HOSPITAL THIS MORNING THAT THEY WERE HAVING TROUBLE INSERTING, AND REMOVING THE (213710) 10MM ROD IN THE BTB GUIDE FRAME 213702. THEY FOUND THIS DURING/AFTER THE CLEANING AND STERILIZATION PROCESS, NOT DURING THE PROCEDURE. THE TEAM HAS BEEN HAVING ONGOING ISSUE WITH THIS SET AS MOST RECENTLY ON (B)(4) THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10814500 ↗
• MalfunctionSep 15, 2020Mechanical Jam; Mechanical Jam

  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 10536759 ↗
• MalfunctionJan 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL PROCEDURE, IT WAS OBSERVED THAT THE THUMB SCREW BROKE OFF THE CUSTOMER'S RIGIDFIX FEMORAL SOFT TISSUE GUIDE FRAME AND IT COLD WELDED TOGETHER WITH RIGIDFIX FEMORAL ROD 10MM. THE SALES REP STATED WHERE THE SCREW BROKE OFF STAYS OUTSIDE THE PATIENT THEREFORE NOTHING FELL IN THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICES WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE FEMORAL ROD BUT STATED IT IS AN OLDER DEVICE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS THE SAME DEVICES WERE USED TO COMPLETE THE 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 8275953 ↗
• MalfunctionAug 16, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 2 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, 10 MM 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 7788409 ↗
• MalfunctionJul 24, 2018Mechanical Jam; Mechanical Jam

  BEFORE THE CASE, SCRUB TECHNICIAN COMPLAINED OF THE RIGIDFIX SYSTEM SCREW BEING WEAK. INTRAOPERATIVELY, WHILE MALLETING THE RIGIDFIX SYSTEM INTO THE FEMORAL TUNNEL, THE SCREW BROKE IN HALF. THE 10 MM RIGIDFIX GUIDE IS STUCK IN THE BONE TENDON BONE RIGIDFIX GUIDE. WE WERE ABLE TO COMPLETE SURGERY WITH NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713718 ↗
• 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 7596057 ↗
• 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 7596056 ↗