NO BRAND 71158072Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556631720), received between Nov 13, 2019 and May 16, 2022 — classified as 1 injury, 2 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT, THE TIP OF A DEPTH GAUGE FOR 1.8MM PEGS/2.4MM SCREWS BROKE OFF. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY OR NOT, THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407587 ↗
• MalfunctionMay 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE DEPTH GAUGE FOR 1.8MM PEGS/2.4MM SCREWS TIP WAS MISSING. AS THIS WAS NOTICED DURING FIELD INSPECTION, NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860071 ↗
• InjuryNov 13, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING SURGERY THE DEPTH GAUGE APPEARS WAS MISALIGNED BY 2MM OFF. DUE TO THIS SEVERAL SCREWS HAD TO BE SWITCH OUT BECAUSE THEY WERE LONG. NO DELAY WAS REPORTED. NO BACKUP DEVICE WAS NEEDED TO FINISH THE SURGERY BECAUSE SHORTER SCREWS WERE USED.

  Patient problems: Injury

  MAUDE report 9315208 ↗