NA 288200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705026784), received between Nov 25, 2019 and Sep 11, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILISATION PROCEDURE, THE INLINE CORACOID DRILL GUIDE DEVICE DRILL GUIDE TIP WAS BENT AND UNABLE TO PASS OFFSET PIN THROUGH. 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 23031124 ↗
• MalfunctionMay 28, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE BETA HOLE OF THE INLINE CORACOID DRILL GUIDE DEVICE WAS BLOCKED AND WOULD NOT ALLOW THE WIRE TO ADVANCE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094924 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION SURGICAL PROCEDURE THE INLINE CORACOID DRILL GUIDE DEVICE WAS DAMAGED ON ENTRY INTO THE PATIENT AND A METAL PART BROKE OFF. THERE WAS NO DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. AN XRAY WAS PERFORMED AND IT WAS OBSERVED THAT NO PIECES WERE LEFT IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652869 ↗
• MalfunctionMar 3, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 3 OF 3 FOR (B)(4).. IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION IN THE NETHERLANDS THAT DURING INSPECTION, IT WAS OBSERVED THAT THE INLINE CORACOID DRILL GUIDE DEVICE WAS BROKEN AND DIRTY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16480882 ↗
• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PRE-OPERATIVELY TO A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HANDLE ON THE INLINE CORACOID DRILL GUIDE DEVICE WAS CRACKED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202696 ↗
• MalfunctionSep 8, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A LEAD EXTRACTION A INLINE CORACOID DRILL GUIDE WAS BENT AT THE TIP ON INSERTION TO PATIENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION REPORTED BY THE AFFILIATE STATED THE DEVICE WAS PART OF A LOAN KIT AND THE EVENT OCCURRED DURING A LATERJET PROCEDURE. IT WAS ALSO REPORTED THE DEVICE BENT ON ENTRY TO THE PATIENT DURING AN ARTHROSCOPIC LATERJET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10503078 ↗
• MalfunctionNov 25, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN ARTHROSCOPIC WHEN INSERTING THE INLINE CORACOID DRILL GUIDE THE JAGGED EDGE THAT IS DESIGNED TO GRIP INTO THE CARACOID BONE IS THE ONE USUALLY GETTING CLOGGED WITH SOFT TISSUE, AS IT OCCURRED DURING THIS PROCEDURE. NO PATIENT CONSEQUENCE. THE SURGEON HAD TO STOP TO FREE THE EDGE OF THE TISSUE AND THAT CAUSED A SHORT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED A MINOR SURGICAL DELAY CAUSED BY HAVING TO REMOVE THE SOFT TISSUE FROM THE END OF THE INSTRUMENT. THE AFFILIATE ALSO REPORTED THE CASE WAS COMPLETED BUT COULD NOT PROVIDE ADDITIONAL DETAILS BUT DID STATE SURGICAL INTERVENTION WAS NOT REQUIRED. IT WAS ALSO REPORTED SPECIFIC LOT NUMBERS COULD NOT BE PROVIDED. THE AFFILIATE LATER REPORTED THIS WAS NOT A COMPLAINT ABOUT A SPECIFIC INSTRUMENT BUT A COMMENT ABOUT THE DESIGN ON THE INSTRUMENT IN GENERAL. THE SURGEON HAS USED THE INSTRUMENT FROM VARIOUS DEPUY KITS AND THIS IS A COMMENT ABOUT THE CORACOID DRILL GUIDE DESIGN IN GENERAL. THE AFFILIATE REPORTED THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9372491 ↗