RIGIDFIX 213711Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705003051), received between Jul 13, 2018 and Jan 11, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 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.

• MalfunctionJan 11, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020,IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK AND THE RIGIDFIX FEMORAL ROD 11 MM BTB 1PK BROKE AND GOT STUCK TOGETHER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149132 ↗
• MalfunctionSep 27, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THERIGIDFIX FEMROD B/T/B 11 MM EA REPLACEMENT DEVICE DID NOT FIT. 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 THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. 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 9128705 ↗
• MalfunctionSep 26, 2019Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED BY THE AFFILIATE IN NEW (B)(6) THAT DURING AN ACL REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 11MM RIGIDFIX ROD WAS HAVING ISSUE SLIDING INTO AND OUT OF THE RIGIDFIX BTB GUIDE FRAME. ALL THE OTHER SIZES WERE FITTING OKAY. REPLACEMENTS WERE REQUESTED BUT WHEN THEY WERE RECEIVED THEY ALSO DID NOT FIT, SO A LOAN KIT WAS SENT TO BRIDGE THE GAP. 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 9123720 ↗
• MalfunctionJul 13, 2018Mechanical Jam; Mechanical Jam

  THE SALES REP REPORTED THE THUMBSCREW ON THE CUSTOMERS RIGIDFIX BTB FEMORAL GUIDE FRAME BROKE OFF WHILE MALLETING INTO THE DEVICE DURING AN ACL PROCEDURE. HE STATED THIS CAUSED THE CUSTOMERS RIGIDFIX BTB FEMORAL 11MM ROD TO GET STUCK IN THE DEVICE AND COULD NOT BE REMOVED. THE SURGEON WAS FINISHED WITH THE DEVICE AT THIS POINT OF THE PROCEDURE AND COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7687412 ↗