ENDOBUTTON 72201594Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010601452), received between Aug 10, 2018 and Oct 22, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BEFORE AN ACL SURGERY, IT WAS NOTICED THAT THE PACKAGING OF THE FLEXIBLE PASSING PIN WAS FOUND TO BE TAMPERED IN. THE PROCEDURE WAS RESUMED AFTER A DELAY OF TEN (10) MINUTES, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364304 ↗
• MalfunctionOct 20, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE PASSING THE FLEXIBLE PASSING PIN THROUGH THE BONE, A BLACK SUBSTANCE WAS LEFT INSIDE THE JOINT, METALLIC MATERIAL. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490366 ↗
• InjuryMay 4, 2022Break; Break

  IT WAS REPORTED THAT DURING A SINGLE TENDON ACL, THE PIN WAS LOADED INTO THE ORANGE HANDLE BY THE SCRUB NURSE PRIOR TO THE SURGEON ASKING FOR IT, WHEN THE SURGEON APPROACHED THE NOTCH TO DRILL THE TUNNEL, THE EFFORT REQUIRED TO DRILL WAS IMMENSE AND UNUSUAL. ONCE THE PIN CAME OUT OF THE SKIN IT WAS MISSING THE DRILL TIP. X-RAY WAS BROUGHT IN TO FIND THE MISSING TIP AND WAS FOUND BY TWEEZERS IN THE SOFT TISSUE OF THE ACCESS PORTAL. THE MISSING TIP WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A S+N BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283731 ↗
• InjuryAug 18, 2020Break; Break

  IT WAS REPORTED THAT DURING ACL SURGERY WHEN THE SURGEON MADE THE BONE HOLE, THE FLEXIBLE PASSING PIN WAS FOUND TO BE BROKEN; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH MINIMAL DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10422672 ↗
• MalfunctionMar 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, THE FLEXIBLE PASSING PIN BROKE WHEN OVER-DRILLING WITH CLANCY FLEXIBLE DRILLS. IT IS UNKNOWN IF ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ALTHOUGH A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, THE SURGERY WAS DELAYED FOR MORE THAN 30 MIN. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9821718 ↗
• MalfunctionFeb 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE 2.4MM FLEXIBLE PASSING PIN BROKE INSIDE THE PATIENT. BROKEN PIECES WERE REMOVED WITH TWEEZERS. THEN SURGEON REPEATED THE SAME TECHNIQUE WITH A NEW PIN AND REAMER THROUGH A SLIGHTLY DIFFERENT PORTAL AND IT WENT PERFECTLY FROM THERE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY AND NO PATIENT INJURIES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9720084 ↗
• MalfunctionJan 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE THE PASSING PIN WAS BREAKING IN HALF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9634738 ↗
• MalfunctionJan 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE THE PASSING PIN WAS BREAKING IN HALF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9634598 ↗
• MalfunctionDec 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE THE PASSING PIN WAS BREAKING IN HALF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9443037 ↗
• MalfunctionDec 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE THE PASSING PIN WAS BREAKING IN HALF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9443012 ↗
• MalfunctionJul 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ACL PROCEDURE THE DEVICE BROKE WHILE PIERCING THE TUNNEL. BACKUP DEVICE WAS AVAILABLE. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8773617 ↗
• MalfunctionMar 12, 2019Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE FLEXIBLE PASSING PIN BROKE WHILE BEING DRILLED INTO THE FEMUR. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED. THE BROKEN PASSING PIN WAS COMPLETELY REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8413088 ↗
• MalfunctionMar 12, 2019Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE FLEXIBLE PASSING PIN BROKE WHILE BEING DRILLED INTO THE FEMUR. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED. THE BROKEN PASSING PIN WAS COMPLETELY REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412959 ↗
• MalfunctionMar 5, 2019Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, THE DEVICE BROKE INTO THE FEMUR. ALL PIECES WERE REMOVED FROM PATIENT. A BACK UP WAS AVAILABLE AND IT WAS USED NEXT TO THE ORIGINAL HOLE. NO DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8392857 ↗
• MalfunctionDec 10, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A LIGAMENTPLASTY THE FLEXIBLE PASSING PIN COMPLETELY LOOSENED THE MARKS LEAVING THE JOINT COMPARTMENT FULL OF FRAGMENTS. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149304 ↗
• MalfunctionAug 10, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL REPAIR PROCEDURE, WHEN FEMORAL BONE HOLE PREP, PIN BROKE OFF AT 4MM FROM TIP. THE BROKEN TIP WAS RETRIEVED FROM PATIENT. NO PATIENT INJURY, BUT 60 MINUTES DELAY WAS REPORTED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7774554 ↗
• MalfunctionAug 10, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL REPAIR PROCEDURE, WHEN FEMORAL BONE HOLE PREP, PIN BROKE OFF AT 2MM FROM TIP.THE SURGEON THINKS THAT THE PIN WAS BROKEN IMMEDIATELY FROM START DRILL. THE BROKEN TIP WAS RETRIEVED FROM PATIENT. NO PATIENT INJURY, BUT 60 MINUTES DELAY WAS REPORTED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7774547 ↗