Hex Tool Short HT1.25SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10841307119678), received between Jul 5, 2019 and Sep 30, 2022 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 reports).

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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2022Material Deformation; Material Deformation

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS DEFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 15515355 ↗
• InjurySep 5, 2022Material Deformation; Material Deformation

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DEFORMATION WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 15355351 ↗
• InjuryAug 9, 2022Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 15196475 ↗
• InjuryMar 24, 2022Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 13891627 ↗
• InjuryMar 24, 2022Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 13891032 ↗
• InjuryOct 12, 2021Fracture; Fracture

  PER COMPLAINT (B)(4), PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 12615131 ↗
• InjuryOct 12, 2021Fracture; Fracture

  PER COMPLAINT (B)(4), PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 12615120 ↗
• MalfunctionMay 26, 2021Separation Failure; Osseointegration Problem; Separation Failure; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11884383 ↗
• MalfunctionOct 22, 2020Fracture; Fracture

  PER COMPLAINT (B)(4), PRODUCT FRACTURED IS EXPERIENCED.

  Patient problems: Failure of Implant

  MAUDE report 10716874 ↗
• InjuryOct 22, 2020Fracture; Fracture

  PER COMPLAINT (B)(4), PRODUCT FRACTURED IS EXPERIENCED.

  Patient problems: Failure of Implant

  MAUDE report 10716869 ↗
• MalfunctionNov 28, 2019Defective Device; Defective Device

  PER COMPLAINT (B)(4), HT1.25S AND HT1.25 HEX TOOL BENT WHILE REMOVING HEALING CAP.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9389850 ↗
• MalfunctionJul 5, 2019Material Integrity Problem; Material Integrity Problem

  PER COMPLAINT (B)(4), DURING THE CLINICAL PROCEDURE, THE DOCTOR COULD NOT REMOVE THE IMPRESSION POST AND STRIPPED 3 DRIVERS. PER THE COMPLAINT, THE DOCTOR STATES THAT HE DID NOT USE A TORQUE WRENCH TO TIGHTEN SCREW BUT WHEN HE TRIED TO REMOVE THE SCREW FROM THE IMPLANT IT WAS STUCK. HE HAS STRIPPED OR BROKEN MULTIPLE TIPS AND TRIED THE ULTRA SONIC TO TRY TO BREAK UP ANYTHING WEDGING THE ABUTMENT IN PLACE, NOTHING WORKED. ADDITIONALLY, THE DOCTOR HAS APPLIED TO UP TO 60 NCM OF COUNTERCLOCKWISE TORQUE AND THE SCREW WOULDN'T MOVE. THE IMPLANT WAS EXTRACTED.

  Patient problems: No Information

  MAUDE report 8765253 ↗