Skip to content

TRACKER 215187Recalls & reported problems

Depuy Mitek, LLC · TRACKER MODULE · 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 10886705004607), received between Jul 25, 2018 and Jul 25, 2018 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionJul 25, 2018Break; Break

    IT WAS REPORTED BY THE DISTRIBUTOR THAT AFTER AN ANTERIOR CRUCIATE LIGAMENT REPAIR, IT WAS OBSERVED THAT TRACKER GUIDE MODULE BROKE ON THE BOTTOM. THERE WERE NO INSTRUMENTS THAT FELL OUT BUT THE TRAY IS NOW UNUSABLE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAY. THE DISTRIBUTOR COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT REPORTED IT WAS OVER TWO YEARS OLD AND HAD SEEN HEAVY USE. 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 7720145 ↗

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.