Hex Tool Short HT2.5SRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307119708), received between Apr 30, 2018 and Sep 26, 2019 — classified as 2 injuries, 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 18, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Material Deformation1
- Separation Failure1
- Separation Problem1
Patient problems
- Failure of Implant1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Information1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2019Separation Failure; Material Deformation; Separation Failure; Material Deformation
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, IT WAS OBSERVED THAT THE COMPONENT COULD NOT BE SEPARATED.
Patient problems: Failure of Implant; No Information
MAUDE report 9121936 ↗MalfunctionSep 6, 2018Separation Problem; Separation Problem
PER COMPLAINT (B)(4), DURING THE OSTEOTOMY, THE IMPLANT BECAME STUCK MIDWAY. THE DOCTOR WAS UNABLE TO REMOVE THE IMPLANT WITHOUT DAMAGING THE IMPLANT OR INSTRUMENTS. THERE WAS NO ADVERSE IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7853709 ↗InjuryApr 30, 2018Device-Device Incompatibility; Device-Device Incompatibility
DRIVERS STUCK TO IMPLANT AND REQUIRED SO MUCH FORCE TO DISENGAGE THAT IT REMOVED IMPLANT & COULDN'T BE ENGAGED AGAIN. IMPLANT WAS REMOVED AND A SECOND SURGERY WAS REQUIRED. THIS IS A REPORTABLE SERIOUS INJURY.
Patient problems: No Code Available; Osteopenia/ Osteoporosis
MAUDE report 7474594 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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