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Apache 1 (REF GAC100-XS)Recalls & reported problems

Genesys Orthopedics Systems LLC · AIS-C X-Small Inserter · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 M719GAC100XS0), received between Aug 29, 2019 and Aug 29, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 29, 2019Break; Break

    A PUSHER ARM OF A GAC100-XS EXTRA SMALL AIS-C ANCHORED INSERTER BROKE DURING A PROCEDURE. THIS CAUSED A DELAY IN THE PROCEDURE OF LESS THAN 10 MINUTES AS THE BROKEN COMPONENT WAS RETRIEVED. THE SURGEON USED AN AVAILABLE BACKUP DRIVER AND COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8945107 ↗

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Sources and updates

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