NA 288202Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886705026807), received between Feb 14, 2020 and Jun 3, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Degraded” (9 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 12, 2017Terminated

   Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

   Z-2617-2017 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Crack

  IT WAS REPORTED THAT DRILL BIT ON THE CORACOID TOP HAT DRILL HAD A CRACK IN THE TIP. THE EVENT OCCURRED DURING HANDLING AND PRIOR TO INSERTION. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371894 ↗
• MalfunctionJun 3, 2026Crack

  IT WAS REPORTED THAT DRILL BIT ON THE CORACOID TOP HAT DRILL HAD A CRACK IN THE TIP. THE EVENT OCCURRED DURING HANDLING AND PRIOR TO INSERTION. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371893 ↗
• MalfunctionDec 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE UNSPECIFIED SURGICAL PROCEDURE THE CORACOID TOP HAT DRILL DEVICE HAD BONE IN IT. IT IS UNKNOWN WHETHER ANOTHER 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 23727370 ↗
• 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 1 OF 3 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891152 ↗
• MalfunctionNov 13, 2024Degraded; Degraded

  IT WAS REPORTED FROM AUSTRALIA THAT TWO SETS OF DEVICES HAD BLUNT INSTRUMENTS. IT WAS REPORTED THAT THE TWO CORACOID TOP HAT DRILL DEVICES, AND TWO SHARP CURVED OSTEOTOME DEVICES 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 3 OF 4 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677337 ↗
• MalfunctionNov 13, 2024Degraded; Degraded

  IT WAS REPORTED FROM AUSTRALIA THAT TWO SETS OF DEVICES HAD BLUNT INSTRUMENTS. IT WAS REPORTED THAT THE TWO CORACOID TOP HAT DRILL DEVICES, AND TWO SHARP CURVED OSTEOTOME DEVICES 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 1 OF 4 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677277 ↗
• MalfunctionSep 26, 2024Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP FROM CANADA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE CORACOID TOP HAT DRILL DEVICE TOP HAT DRILL WAS DULL. IT WAS UNKNOWN IF A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE OR IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF A THERE WAS A DELAY TO 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 20314495 ↗
• MalfunctionAug 26, 2024Degraded; Degraded

  IT WAS REPORTED FROM THE SALES REP THAT DURING DEVICE INSPECTION IT WAS OBSERVED THAT THE CORACOID TOP HAT DRILL DEVICE WAS BLUNT PRIOR TO USE. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071374 ↗
• MalfunctionDec 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE CORACOID TOP HAT DRILL DEVICE SEEMED BENT. IT WAS REPOSITIONED IN THE CHUCK BUT IT DIDN'T HELP. THE DRILL IS DEFINITALY BENT. 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 18276858 ↗
• MalfunctionApr 19, 2023Degraded; Degraded

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE CORACOID TOP HAT DRILL DEVICE WAS BLUNT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 16772755 ↗
• MalfunctionMar 8, 2023Degraded; Degraded

  THIS IS REPORT 1 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 CORACOID TOP HAT DRILL 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 16504399 ↗
• MalfunctionOct 7, 2022Degraded; Degraded

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A POSTERIOR BONE BLOCK PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE CORACOID TOP HAT DRILL DEVICE WAS BLUNT. 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 15564535 ↗
• MalfunctionMar 28, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN AUSTRALIA THAT DURING A LACERATION CLOSURE PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE K-WIRE GOT STUCK IN CANNULATION ON THE CORACOID TOP HAT DRILL DEVICE. THE K-WIRE WAS REMOVED WITH COCKER TO COMPLETE THE PROCEDURE. 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 13931684 ↗
• InjuryMay 7, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE CORACOID TOP HAT DRILL DEVICE WAS BLUNT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11791804 ↗
• MalfunctionFeb 14, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE CORACOID TOP HAT DRILL WAS SLIGHTLY BENT, AND WHEN PERFORMING THE PROCEDURE IT WAS ECCENTRIC DRILLING OF THE HOLE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712658 ↗