NA 310.288Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982186423), received between Jan 3, 2017 and May 1, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Failure to Cut

  IT WAS REPORTED THE DRILL BITS WOULD NOT CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056807 ↗
• MalfunctionApr 17, 2026Break

  DURING THE PROCEDURE, THE DRILL BIT BROKE. THE SURGICAL INSTRUMENT TECHNICIAN WAS INFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910960 ↗
• MalfunctionDec 19, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THE TIP OF THE DRILL BIT BROKE INSIDE THE BONE. IT WAS NOTED THAT THE TIP REMAINED IN THE PATIENT, BUT THERE HAVE BEEN NO REPORTS OF COMPLICATIONS DUE TO IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23849632 ↗
• MalfunctionFeb 26, 2024Break; Break

  THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785270 ↗
• MalfunctionOct 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SURGEON ATTEMPTED TO PUT A GUIDE BLOCK AND SCREW THROUGH THE DRILL HOLES. THE ISSUE OCCURRED WHILE THE ATTACHMENT SCREW GOING TO THE PATIENT'S BODY VIA THE GUIDE BLOCK. WE ARE DOING A DISTAL FIBULA PLATE FOR A PATIENT AND DRILLED FOR A LOCKING SCREW THEN USE THE POWER SHAFT. THE LOCKING SCREW WOULD NOT STICK TO THE TIP OF THE SCREWDRIVER SHAFT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE HAND SCREWDRIVER AND A SURGICAL DELAY OF (30) SECONDS. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: DISTAL RADIUS: (PART#UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS REPORT IS FOR (1) 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665178 ↗
• MalfunctionDec 13, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT UPON OPENING THE SET IT WAS FOUND THAT THE TWO (2) DRILL BITS WERE BROKEN AND UNABLE TO USE. CUSTOMER BELIEVES THAT THESE WERE SENT OUT AS BROKEN AS NOBODY HAD TOUCHED IT BEFORE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468509 ↗
• MalfunctionDec 4, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT (B)(6) ADVISED (B)(6) WHEN THEY OPENED THE SET TO USE IT, THEY FOUND ITEM 310.288 DRILL BIT BROKEN AND UNABLE TO USE IT. THEY BELIEVE THIS WAS SENT OUT BROKEN AS NOBODY HAD TOUCHED IT BEFORE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412595 ↗
• MalfunctionAug 6, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE DRILL BIT HAD AN UNFINISHED, BLACK BLEMISH. THIS WAS DISCOVERED IN THE RECEIVING AREA. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.8MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8864818 ↗
• MalfunctionJun 21, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON COMPLAINED THAT THE LOCKING COMPRESSION PLATES (LCP) SMALL FRAGMENT DRILL BITS WERE DULL OR MIS ENGINEERED. THE QUICK COUPLING DRILL BIT 110 MM,  QUICK COUPLING DRILL BIT 165 MM, AND  PERCUTANEOUS DRILL BIT WERE USED FOR A CASE, SWAPPED AND SWITCH TO ENSURE NEW FRESH BITS WERE USED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.  THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8724877 ↗
• MalfunctionApr 24, 2019Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING A WRIST FUSION PROCEDURE, THE DRILL BIT BECAME BLUNT DURING THE FIRST SCREW INSERTION. THE SURGEON USED ANOTHER DRILL BIT FROM THE SET TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCE WAS REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544079 ↗
• MalfunctionDec 28, 2018Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL HUMERUS ON AN UNKNOWN DATE, THE DRILL BIT BROKE WHEN HITTING A SCREW WITH FORCE. THE BROKEN PORTION OF DRILL WAS COMPLETELY REMOVED. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS WAS AS EXPECTED. CONCOMITANT DEVICE: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8203801 ↗
• InjuryJul 11, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, A DRILL BIT BROKE IN A PATIENT AS THE SURGEON WAS INTENTIONALLY DRILLING INTO AN EXISTING SCREW. HALF OF THE DRILL BIT WAS RECOVERED FROM THE PATIENT WHILE THE OTHER HALF WAS LEFT IN THE PATIENT. INITIALLY, THE SURGEON HAD NO INTENTION OF DRILLING IN AN EXISTING SCREW, BUT GRADUALLY DECIDED TO DRILL IT SO THAT THE SCREW WOULD FIT IN THE PROPER DIRECTION. AS HE WAS TRYING TO MOVE THE SCREW TO THE PROPER DIRECTION HE TRIED TO FORCE THE DRILL AND AFTER SOME TIME THE DRILL BIT BROKE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7677303 ↗
• InjuryJan 3, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2016 TO TREAT A PROXIMAL HUMERUS FRACTURE. DURING THE PROCEDURE WHILE THE SURGEON WAS DRILLING FOR SCREW PLACEMENT THE 2.8 MM DRILL BIT BROKE OFF IN THE PATIENT. THE FRAGMENT PIECE WAS NOT RETRIEVED BECAUSE THE SURGEON FELT THAT IT WOULD CAUSE FURTHER BONE DESTRUCTION. AN X-RAY TAKEN AT THE TIME SHOWED THE FRAGMENT FINDING. ANOTHER DRILL BIT WAS AVAILABLE FOR THE SURGEON TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: SCREW (QUANTITY 1). THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6219400 ↗