Skip to content

RIGIDFIX 213717Recalls & reported problems

Medos International Sàrl · RIGIDFIX Femoral Rod Soft Tissue Only 7.5mm, 30-120mm (Plus or Minus 6 Percent) · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705003082), received between Jan 21, 2019 and Jan 21, 2019 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 21, 2019Fracture; Fracture

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THUMB SCREW BROKE OFF CAUSING THEIR RIGIDFIX FEMORAL ROD 7.5MM AND THEIR RIGIDFIX FEMORAL ST GUIDE FRAME TO BE STUCK TOGETHER. THE SALES REP STATED THAT THEY ARE UNABLE TO GET THE BROKEN PIECE OUT THAT ARE CAUSING THE TWO PIECES TO BE REMOVED FROM ONE ANOTHER. 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 PROCEDURE. THE SALES REP STATED THAT WHERE THE DEVICE BROKE STAYS OUTSIDE THE PATIENT. THE SALES REP CONFIRMED THAT NOTHING BROKE OR FELL IN THE PATIENT. THE SALES REP COULD NOT PROVIDE ANY LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE OVER FIVE YEARS OLD AND 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 ACCO

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8264790 ↗

Other Guide, surgical, instrument devices

All Guide, surgical, instrument devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.