NA 204.880Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982146588), received between Feb 3, 2021 and Aug 4, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE DRILLING IN THE DISTAL HUMERUS, THE SURGEON BROKE OFF THE END OF THE 2.5 DRILL BIT. THE FRAGMENT REMAINED IN THE PATIENT. THE SURGEON ELECTED TO NOT ATTEMPT TO REMOVE THE DRILL. WHILE INSERTING A 3.5 CORTEX SCREW THROUGH THE SAME DRILL HOLE, THE NEAR PORTION OF THE SCREW BROKE. THE SCREW FRAGMENTS WERE REMOVED, AND A SHORTER SCREW WAS PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES/OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1)3.5MM CORTEX SCREW SELF-TAPPING 80MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15166027 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE SURGEON WAS REMOVING A PLATE AND 9 SCREWS FROM THIS PATIENT. DURING THE REMOVAL 3 OF THE 3.5MM SCREW HEADS BROKE OFF INTO THE PATIENT. THESE 3 SCREWS REMAINED IN THE PATIENT. HE ALSO REMOVED A PLATE AND 6 SCREWS ALL OF WHICH WERE REMOVED SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 80MM. THIS IS REPORT 6 OF 10 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274491 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE SURGEON WAS REMOVING A PLATE AND 9 SCREWS FROM THIS PATIENT. DURING THE REMOVAL 3 OF THE 3.5MM SCREW HEADS BROKE OFF INTO THE PATIENT. THESE 3 SCREWS REMAINED IN THE PATIENT. HE ALSO REMOVED A PLATE AND 6 SCREWS ALL OF WHICH WERE REMOVED SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 80MM. THIS IS REPORT 5 OF 10 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273871 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE SURGEON WAS REMOVING A PLATE AND 9 SCREWS FROM THIS PATIENT. DURING THE REMOVAL 3 OF THE 3.5MM SCREW HEADS BROKE OFF INTO THE PATIENT. THESE 3 SCREWS REMAINED IN THE PATIENT. HE ALSO REMOVED A PLATE AND 6 SCREWS ALL OF WHICH WERE REMOVED SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 80MM. THIS IS REPORT 1 OF 10 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273857 ↗