ENDOBUTTON 014396Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010374691), received between Nov 12, 2018 and Nov 19, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT, WHEN USING THE DRILL TIP GUIDE WIRE, METAL SHAVINGS WERE SEEN INSIDE THE PATIENT'S JOINT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723221 ↗
• MalfunctionNov 4, 2020Melted; Melted

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE PACKAGE WAS OPENED, THE PIECE OF THE CAP WAS COMPLETELY ADHERED TO THE ROD WHEN IT WAS TRIED TO BE REMOVED. 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 10784700 ↗
• MalfunctionOct 7, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, WHEN THE PACKAGE OF THE "2.4MM DRILL TIP GUIDE WIRE" WAS OPENED AND CHECKED, IT WAS FOUND THE STERILE POUCH WAS NOT SEALED PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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; No Known Impact Or Consequence To Patient

  MAUDE report 10645930 ↗
• MalfunctionAug 8, 2020Problem with Sterilization; Problem with Sterilization

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE PACKAGE OF THE DRILL WAS OPENED, THE FILM DID NOT COME OFF FROM THE STERILIZATION PATCH AND THE DEVICE BECAME FILTHY. 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 10383079 ↗
• MalfunctionJul 22, 2020Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE PACKAGE WAS OPENED AND THE RUBBER PROTECTIVE CAP WAS REMOVED FROM THE ROD, A PIECE OF THE CAP WAS COMPLETELY ADHERED TO THE ROD. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311567 ↗
• MalfunctionJul 14, 2020Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT, DURING SET UP FOR A PROCEDURE, THE GUIDE WIRE'S PACKAGE WAS OPENED AND THE RUBBER PROTECTIVE CAP REMOVED. IT WAS NOTICED THAT A PIECE OF THE PROTECTIVE CAP WAS COMPLETELY ADHERED TO THE ROD. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR FURTHER COMPLICATIONS WERE NOTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10273067 ↗
• MalfunctionJun 22, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SET UP, WHEN THE PACKAGE OF THE DRILL TIP GUIDE WIRE WAS OPENED AND THE RUBBER PROTECTIVE CAP WAS REMOVED FROM THE ROD, A PIECE OF THE CAP WAS COMPLETELY ADHERED TO THE ROD. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181930 ↗
• MalfunctionApr 19, 2019Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, THE DRILL TIP GUIDE WIRE BROKE. THE BROKEN PIECE WAS REMOVED FROM THE BODY WITH A GRASPER. THE SURGERY HAD BEEN FINISHED WITH THE SAME DEVICE BUT WAS EXTENDED FOR 5 MIN MORE AS CONSEQUENCE OF THE ALLEGED MALFUNCTION. THE PATIENT, WHO HAD A HARD BONE QUALITY, DID NOT SUFFER ANY ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8531974 ↗
• MalfunctionApr 5, 2019Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN INTO THE PATIENT AND PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8486955 ↗
• MalfunctionNov 12, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE BROKE OFF. BROKEN PIECE WAS REMOVED FROM PATIENT. NO PATIENT INJURY OR DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8061305 ↗