Skip to content

Hex Button 400-783Recalls & reported problems

Pioneer Surgical Technology, Inc. · Hex Button 3.5mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468064020), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (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

  • Device Handling Problem1
  • Expiration Date Error1
  • Use of Incorrect Control/Treatment Settings1

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.

  • InjuryFeb 3, 2022Use of Incorrect Control/Treatment Settings; Expiration Date Error; Device Handling Problem; Use of Incorrect Control/Treatment Settings; Expiration Date Error; Device Handling Problem

    "THE SAP SYSTEM HAS INFORMED US THAT 1 EXPIRED PRODUCT HAS BEEN CONSUMED IN A SURGERY WHEN THE PRODUCT WAS BEING INVOICING. THE PRODUCT EXPIRED ON 17.08.2021 AND WAS USED IN A SURGERY ON (B)(6) 2021. NEITHER IMPACT IN PATIENT NOR CLAIM OR INCIDENCE HAS BEEN INFORMED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13446191 ↗

Other Washer, Bolt Nut devices

All Washer, Bolt Nut devices →

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