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GII 212094Recalls & reported problems

Depuy Mitek, LLC · GII Inserter · 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 10886705001910), received between Dec 1, 2020 and Dec 1, 2020 — 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 Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 1, 2020Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING A DISTAL BICEP PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE METAL PRONGS ON THE INSERTER GII BROKE OFF WHILE THE SURGEON WAS MALLETING IN THE ANCHOR. ACCORDING TO THE REPORT, THE PRONG HAD TO BE REMOVED FROM THE ANCHOR BECAUSE IT BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A ONE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10927854 ↗

Other APPLIER, STAPLE, SURGICAL, devices

All APPLIER, STAPLE, SURGICAL, devices →

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