NA 288206Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705026845), received between Aug 18, 2020 and Sep 8, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LATARJET SURGERY, IT WAS OBSERVED THAT THE CORACOID OFFSET PIN BENT DURING USE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990847 ↗
• MalfunctionFeb 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE CORACOID OFFSET PIN DEVICE WAS BENT. IT WAS REPORTED THAT THE DEVICE WAS OBSERVED TO BE BENT BEFORE USING IT. 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 21302519 ↗
• MalfunctionJan 23, 2025Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  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 6 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217797 ↗
• MalfunctionNov 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED FROM AUSTRALIA THAT THE CORACOID OFFSET PIN WAS BENT. IT WAS NOT REPORTED IF THIS EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712229 ↗
• MalfunctionMar 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT POSTOPERATIVELY TO A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE CORACOID OFFSET PIN DEVICE WAS BENT. 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 13635496 ↗
• MalfunctionFeb 3, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT THE CORACOID OFFSET PIN WAS BENT INSIDE THE DRILL GUIDE AND COULD NOT BE DISASSEMBLED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13445200 ↗
• MalfunctionJun 1, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN LATERJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE CORACOID OFFSET PIN DEVICE SNAPPED IN THE PATIENT. IT WAS RETRIEVED AND PROCEDURE WAS COMPLETED WITH A DELAY OF ONE MINUTE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916299 ↗
• MalfunctionJan 15, 2021Break

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A GLENOID RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PIN DEVICE BROKE OFF. THERE WERE NO FRAGMENTS GENERATED. ANOTHER LIKE 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 11179864 ↗
• MalfunctionAug 18, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER REPAIR, WHILE USING A CORACOID OFFSET PIN, THE SURGEON NOTICED THE OFFSET PIN ON THE CORACOID DRILL GUIDE WAS BENT. SURGEON HAD TO BENT THE PIN BACK TO NORMAL TO COMPLETE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420438 ↗