NA 03.133.100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982277367), received between Aug 9, 2023 and Feb 26, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. POSTOPERATIVE X-RAY REVEALED WHAT APPEARED TO BE A METAL FRAGMENT NEAR THE CLAVICLE FRACTURE SITE. THE SURGEON DID NOT NOTICE IT DURING THE SURGERY. THE METAL FRAGMENT COULD BE A K-WIRE FOR TEMPORARY FIXATION, SCREW, OR DRILL BIT. THE K-WIRE IS A COMPETITOR¿S PRODUCT. A PLATE REMOVAL OPERATION IS SCHEDULED FOR EARLY (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM DRILL BIT QC 110MM STER 30MM CALIBRATION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18776725 ↗
• MalfunctionAug 14, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL HUMERUS FRACTURE WITH THE DRILL BIT IN QUESTION. WHILE DRILLING TO FIX A VADHP PLATE WITH A DISTAL 2.7 SCREW, THE DRILL BIT BROKE OFF IN THE PATIENT¿S BODY. ABOUT 5 MM OF THE TIP REMAINED IN THE BONE. THE OTHER SCREW HOLES WERE FIXED, AND THE SURGERY WAS COMPLETED WITH THE DRILL BIT LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM DRILL BIT QC 110MM STER 30MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540275 ↗
• MalfunctionAug 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(4) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR CLAVICLE FRACTURE. WHEN THE SURGEON ATTEMPTED TO PUT THE DRILL BIT IN QUESTION THROUGH A DRILL GUIDE, IT WOULD NOT GO THROUGH. ANOTHER DRILL BIT WAS ABLE TO PASS THROUGH THE DRILL GUIDE, SO IT WAS USED IN THE PROCEDURE INSTEAD. NO FRAGMENTS WERE GENERATED AND THERE WAS NO ADVERSE PATIENT IMPACT REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH UNDER 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM DRILL BIT QC 110MM STER 30MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17488016 ↗