NA 312.77Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982187949), received between Feb 9, 2023 and Feb 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 ANIMAL HEALTH DID AN IN-HOUSE ORDER FOR A 4.5MM HEADLESS COMPRESSION SCREW SET. WHEN THE SET ARRIVED AN ANIMAL HEALTH EMPLOYEE CONFIGURED THE SET. IT WAS DETERMINED THE 9.5/7.0MM PROTECTION SLEEVE DOES NOT FIT THE 4.5MM HEADLESS COMPRESSION SCREW ASSEMBLY TRAY OF THE GRAPHIC CASE AS IT SHOULD. IT APPEARS EITHER THE PROTECTION SLEEVE HANDLE IS TOO LONG OR THE ASSEMBLY TRAY BRACKET WAS POSITION INCORRECTLY OR MADE TO THE WRONG SPECIFICATION, NOT ALLOWING THE PROTECTION SLEEVE TO PROPERLY FIT AS SHOWN IN THE TECHNIQUE GUIDE OR ON THE ETCHING OF THE ASSEMBLY TRAY. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 9.5MM/7.0MM PROTECTION SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16337239 ↗