COMPASS HINGE 71060001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010328212), received between Oct 23, 2017 and Aug 17, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 17, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN EXTERNAL FIXATION SURGERY, THE T-BOLT FROM A COMPASS UNIVERSAL HINGE BROKE. THIS EVENT WAS SOLVED BY A REPLACEMENT SENT TO THE PATIENT ON (B)(6) 2021. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332000 ↗
• InjuryAug 3, 2020Break; Break

  IT WAS REPORTED THAT A COMPASS UNIVERSAL HINGE WAS PUT ON THE PATIENT AND BROKE 4 WEEKS AFTER THE SURGERY. THE BROKEN PIECE WAS REPLACED WITH A SMITH AND NEPHEW DEVICE.

  Patient problems: Injury

  MAUDE report 10356562 ↗
• InjuryOct 23, 2017Component Missing

  IT WAS REPORTED THAT WHEN THIS ITEM WAS TAKEN TO SURGERY, IT WAS DISCOVERED THAT ONE OF THE TWO T-BOLTS WAS MISSING. HOSPITAL IMPROVISED 16MM BOLT TO SUBSTITUTE & CONTINUED CASE AS NORMAL. SURGICAL EXTENSION > 30 MINUTES.

  Patient problems: No Code Available; No Information

  MAUDE report 6968065 ↗