NA 288204Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705026821), received between Apr 15, 2021 and Aug 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Degraded” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE CORACOID TOP HAT DRILL DEVICE, SHARP CURVED OSTEOTOME DEVICE, LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE AND THE COMBO SCREWDRIVER DEVICE IT WAS OBSERVED THAT THE DEVICES WERE BLUNT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891194 ↗
• MalfunctionNov 13, 2024Degraded; Degraded

  EVENT DESCRIPTION UPDATE: IT WAS REPORTED FROM AUSTRALIA THAT TWO SETS OF DEVICES HAD BLUNT INSTRUMENTS. IT WAS REPORTED THAT THE TWO CORACOID TOP HAT DRILL DEVICES, TWO SHARP CURVED OSTEOTOME DEVICES, A COMBO SCREWDRIVER, AND A CORACOID OFFSET PIN WERE BLUNT. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 4 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677533 ↗
• MalfunctionNov 13, 2024Degraded; Degraded

  EVENT DESCRIPTION UPDATED: IT WAS REPORTED FROM AUSTRALIA THAT TWO SETS OF DEVICES HAD BLUNT INSTRUMENTS. IT WAS REPORTED THAT THE TWO CORACOID TOP HAT DRILL DEVICES, TWO SHARP CURVED OSTEOTOME DEVICES, A COMBO SCREWDRIVER, AND A CORACOID OFFSET PIN WERE BLUNT. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677319 ↗
• MalfunctionJan 16, 2024Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP FROM AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE SHARP CURVED OSTEOTOME DEVICE TORNADO SHAVER WAS MAKING A HIGH PITCHED SCREECHING NOW AND THE OSTEOTOME WAS BLUNT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519928 ↗
• MalfunctionMar 8, 2023Degraded; Degraded

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SHARP CURVED OSTEOTOME DEVICE WAS BLUNT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504403 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING A LATARJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE OSTEOTOME DEVICE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673513 ↗