ENDOBUTTON 7210080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010001214), received between Aug 22, 2019 and Mar 31, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE ENDOBUTTON WENT THROUGH THE BTB GRAFT AND MEASURED THE LENGTH, THE ENDOBUTTON CLBTB LOOP LENGTH WAS FOUND TO BE LONGER (25MM) THAN SPECIFIED (20MM). THE PROCEDURE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11596936 ↗
• MalfunctionNov 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE TIME OF THE PATELLAR GRAFT PASSAGE, DEVICE BROKE INSIDE THE PATIENT, PIECES WERE RETRIEVED FROM THE PATIENT. NO DELAY OR PATIENT INJURIES REPORTED, BACK-UP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. 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 9302689 ↗
• MalfunctionOct 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CROSSED LIGAMENT SURGERY, THE GRAFT WAS PASSED THROUGH THE TUNNELS, THREADS THAT GUIDE THE ENDOBUTTON PLATE WERE TRACED AND AN APPROPRIATE LOCK OF THE PLATE WAS ACHIEVED IN THE PREVIOUS CORTICAL. AT THE TIME OF PULLING THE GRAFT DOWN TO VERIFY THE STABILITY OF THE GRAFT, THE ENDOBUTTON POLYESTER LOOP WAS BROKEN, PRODUCING IN THIS WAY THE FAILURE OF THE TECHNIQUE AND RETURNING THROUGH THE GRAFT TUNNELS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THE SURGICAL HAD A DELAY GREATER THAN 2 HOURS. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9157210 ↗
• MalfunctionSep 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SURGERY, THE PREPARATION OF THE BONE HOLES WAS PERFORMED ACCORDING TO THE REQUIRED TECHNIQUE AND IT WAS SUCCESSFULLY COMPLETED WITHOUT ISSUES. IT WAS VERIFIED THAT THE PLATE WAS COMPLETELY VERTICAL, THE RESPECTIVE ULTRABRAID SUTURE STRANDS WITH DIFFERENT COLOR WERE PLACED TO DISTINGUISH THEM. THE GRAFT WAS TRIED APPROXIMATELY 10 TIMES, BUT THE PLATE NEVER TURNED. THE PIN WAS PASSED, THE 4.5 ENDOBUTTON DRILL BIT, EVEN EXTENDED UP TO 5MM THROUGH THE TWO CORTICES, TUNNEL WAS MEASURED AND THE RESULT WAS 48MM DRAG OF THE CORTEX. IT WAS DRILLED WITH 10MM DRILL BIT TO A LENGTH OF APPROXIMATELY 34MM, THUS LEAVING A CORTEX OF 14MM, SEEING THAT ENDOBUTTON DID NOT RISE. THEREFORE; THE DOCTOR DECIDED TO EXPAND FEMORAL TUNNEL WITH A DRILL FROM 11 TO 34MM, BUT IT DID NOT HELP EITHER. THE SURGEON FOUND THAT THE BTB ENDOBUTTON DID NOT PASS AND IN ORDER TO LEAVE THE PATIENT IN GOOD CONDITION, FUNCTIONAL AND TO CONCLUDE THE SURGERY, HE DECIDED TO PLACE BIORCI SCREW IN THE FEMUR AND TIBIA, GAINING A SURGICAL DELAY GREATER THAN 2 HOURS. THEREFORE; THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE FROM SMITH AND NEPHEW WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953028 ↗
• MalfunctionAug 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY WHEN THE PACKAGE WAS OPENED, IT WAS NOTICED THAT THE LOOP WAS LOOSE AND FLUFFED ALREADY. THERE WAS NO BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8923310 ↗