RIGIDFIX 213706Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705003006), received between Jun 25, 2018 and Sep 5, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED FROM THE SALES REP IN FRANCE THAT THE RIGIDFIX SLEEVE REMOVE TOOL EA DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE OPTICAL DEVICE WAS FRACTURED. 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 20146776 ↗
• MalfunctionApr 19, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE RIGIDFIX SLEEVE REMOVAL TOOL BROKE. ANOTHER LIKE DEVICE WAS USED 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 16771786 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT HER RIGIDFIX SLEEVE REMOVAL TOOL BROKE IN THE MIDDLE WHEN RECEIVING IT BACK AFTER CLEANING. THE SALES REP STATED THAT THERE WERE NO CASE OR PATIENT INVOLVEMENT. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273723 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S RIGID FIX SLEEVE REMOVAL TOOL BROKE AT THE HEAD OF THE SCREW THAT WAS HOLDING IT TOGETHER AFTER AN ANTERIOR CRUCIATE LIGAMENT ACL SURGICAL PROCEDURE. THE CASE WAS COMPLETED PRIOR TO THE DEVICE BREAKING. THERE WERE 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 8270526 ↗
• MalfunctionJun 25, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT THE SCREW ON THE HANDLE OF THE CUSTOMER'S RIGID FIX PIN REMOVER TOOL BROKE. THE SALES REPRESENTATIVE VERIFIED THAT NOTHING BROKE OR FELL INSIDE THE PATIENT. THE SURGEON WAS DONE WITH THE PROCEDURE SO THERE WERE NO PATIENT CONSEQUENCES OR DELAY. THE SALES REPRESENTATIVE VERIFIED THAT THE DEVICE WAS OVER FOUR (4) YEARS OLD AND HAD SEEN HEAVY USE. THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7634112 ↗