Guided Surgery Handle Insert 2.3mmD GS-2.3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307122586), received between May 7, 2018 and Dec 11, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2019Osseointegration Problem; Osseointegration Problem

  PER COMPLIANT (B)(4), THE PILOT DRILL APPEARED TO BE STUCK INSIDE THE GUIDE SLEEVE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9453842 ↗
• InjuryMay 7, 2018Device-Device Incompatibility; Device-Device Incompatibility

  WHILE DOING GUIDED SURGERY THE DOCTOR FOUND THE DRILLS WOULDN'T MOVE THROUGH THE INSERTS PAST WERE THE NARROW APEX MEETS THE WIDER PART OF DRILL. BECAUSE DOCTOR HAD TO SKIP DRILL IN THE SEQUENCE THEY COULDN'T GET THE CORRECT SIZE OSTEOTOMY AND THE IMPLANT COULDN'T ACHIEVE STABILITY. THIS IS A REPORTABLE SERIOUS INJURY AND DEVICE MALFUNCTION, REQUIRING SECOND SURGERY TO COMPLETE THE PROCEDURE.

  Patient problems: Failure of Implant; No Information

  MAUDE report 7493105 ↗