NA 310.534Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10886982186751), received between Jul 28, 2017 and Sep 8, 2026 — classified as 13 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50672434 ↗
• MalfunctionSep 4, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50611924 ↗
• MalfunctionMay 1, 2026Failure to Cut

  IT WAS REPORTED THE DRILL BITS WOULD NOT CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057000 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE DRILL BIT BROKE AND WAS REPLACED, WITH ANOTHER UNIT OF THE SAME CHARACTERISTICS, WHICH WAS ALSO INCLUDED IN THE KIT, ALLOWING THE PROCEDURE TO CONTINUE. ONCE THE ULNAR OSTEOTOMY WAS PERFORMED, COMPRESSION WAS ATTEMPTED USING THE COMPRESSION-DISTRACTION GUIDE FROM THE KIT. HOWEVER, DURING COMPRESSION, THE DEVICE BEGAN TO BEND WITHOUT ACHIEVING COMPRESSION, SO IT WAS REMOVED. AN ATTEMPT WAS MADE TO STRAIGHTEN IT BECAUSE IT WAS NEEDED FOR THE SURGICAL PROCEDURE, BUT THIS WAS NOT POSSIBLE AS THE DEVICE BECAME JAMMED, MEANING IT COULD NEITHER ADVANCE NOR RETRACT. DUE TO THIS SITUATION, THE OSTEOTOMY WAS REDUCED USING MATERIALS FROM THE INSTITUTION. THERE WERE EFFECTS ON THE PATIENT DUE TO WHAT HAPPENED, THE PATIENT REQUIRED MORE SURGICAL TIME AND ANESTHESIA WHILE TRYING TO FIX THE DEVICE AND WHILE THE FRAGMENTS OF THE OSTEOTOMY ARE REDUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005225 ↗
• MalfunctionNov 24, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DURING SURGERY, THE DRILL BIT REPORTEDLY DID NOT FUNCTION CORRECTLY DUE TO A LACK OF EDGE. A REPLACEMENT DRILL BIT WAS USED TO CONTINUE THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT IMPACT OR ALTERATION IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633215 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE 2.0 DRILL BIT WAS BEING DRILLED INTO THE BONE, THIS PROBLEM WAS RESOLVED BY REMOVING THE DRILL BIT AND PASSING THE DOCTOR A SECOND DRILL BIT WITH THE SAME CHARACTERISTICS, ALSO INCLUDED WITH THE EQUIPMENT, SUCCESSFULLY COMPLETING THE SURGERY. THIS RESULTED IN NO DISCOMFORT FOR THE SPECIALIST, NO HARM TO THE PATIENT, AND NO DISRUPTION TO THE SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379435 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THE 2.0 DRILL BIT FRACTURED DURING THE PROCEDURE. THE FRAGMENT WAS DISCARDED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965758 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE DRILL BIT WAS BEING DRILLED, THE 2.0 DRILL BIT BROKE. THIS PROBLEM WAS RESOLVED BY REMOVING THE DRILL BIT ALONG WITH ITS FRAGMENTS. ANOTHER DRILL BIT WITH THE SAME CHARACTERISTICS, ALSO INCLUDED WITH THE EQUIPMENT, WAS PASSED TO THE DOCTOR, THUS SUCCESSFULLY COMPLETING THE SURGERY. DUE TO THIS NOVELTY, THERE WAS NO DISCOMFORT ON THE PART OF THE SPECIALIST, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, AND THERE WERE NO ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629464 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT WAS BROKEN IN THE SURGICAL PROCEDURE; THERE IS NO PART OF THE DRILL BIT LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586616 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PERFORATION OF THE BONE THE TIP OF THE BIT IS BROKEN, THE FRAGMENT IS RECOVERED AND DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554854 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DRILL BIT IN QUESTION. DURING THE DRILLING OF A BONE HOLE, THE DRILL TIP BROKE OFF. THE DRILL TIP WAS BROKEN JUST LONG ENOUGH TO BE GRASPED WITH PLIERS FROM THE BONE, AND THE DRILL TIP REMAINING IN THE BONE WAS REMOVED USING PLIERS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345108 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS NOTED THAT THE THREAD OF THE INSTRUMENT IS CHISELED. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418808 ↗
• MalfunctionOct 10, 2024Break; Break

  DURING THE SURGERY, WHEN THE SPECIALIST WAS PERFORMING THE DRILLING, THE 2.0 DRILL BIT BROKE. PROMPT SOLUTION WAS GIVEN BY REMOVING THE FRAGMENTS OF THE DRILL BIT THAT WAS BROKEN AND PASSING ANOTHER DRILL BIT OF 2.0, THUS CONTINUING WITH THE PROCEDURE AND AVOIDING ISSUES TO THE SPECIALIST. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418516 ↗
• MalfunctionMay 23, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE SYNREAM REAMING GUIDE BECAME CONTAMINATED DURING USE WITH THE DOCTOR'S GLASSES. SINCE IT DOES NOT HAVE ANOTHER REAMING TREE AND TAKING INTO ACCOUNT THAT WE STILL HAD BURS TO USE, IT HAD TO BE CUT IN ITS OLIVE PART TO BE ABLE TO EXTRACT THE GUIDE AND CHANGE IT FOR A NEW ONE WITHOUT CONTAMINATING THE SURGERY. TWO DRILL BITS FRACTURED DURING USE, BOTH REMAINED INSIDE THE BONE AND IT WAS NOT POSSIBLE TO REMOVE THEM WITHOUT DOING FURTHER DAMAGE. THIS REPORT IS FOR A 2.0MM DRILL BIT W/DEPTH MARK QC/110MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19382226 ↗
• MalfunctionMay 8, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, A DRILL BIT 2.0 WAS BROKEN, IT WAS NOT POSSIBLE TO EXTRACT THE FRAGMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A 2.0MM DRILL BIT W/DEPTH MARK QC/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19269094 ↗
• MalfunctionApr 5, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED INTRAOPERATIVELY ON MARCH 16, 2024 TWO (2) 2.0 DRILL BITS WERE COMPLETELY DULL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT IS LISTED AS STABLE. THIS REPORT IS FOR ONE 2.0MM DRILL BIT W/DEPTH MARK QC/110MM (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051108 ↗
• MalfunctionApr 4, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON MARCH 14, 2024, THAT DURING THE SURGICAL PROCEDURE, THE DRILL BIT IS SPLIT, THE EXCESS IS EXTRACTED AND THE PROCEDURE IS COMPLETED WITHOUT COMPLICATIONS. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2 W/MARKING L110/85 2FLUTE F/ THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19045635 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING THE SURGICAL PROCEDURE THE BITS WERE BROKEN, THE PROCEDURE WAS FINISHED WITHOUT ANY COMPLICATIONS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE DRILL BIT Ø2 W/MARKING L110/85 2FLUTE F/. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888440 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 23, 2024 DURING THE SURGICAL PROCEDURE THE BITS WERE BROKEN, THE PROCEDURE WAS FINISHED WITHOUT ANY COMPLICATIONS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE DRILL BIT Ø2 W/MARKING L110/85 2FLUTE F/ THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888363 ↗
• MalfunctionJan 5, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY WITH THE DRILL BIT IN QUESTION. WHEN DRILLING WAS PERFORMED FOR THE CORTICAL SCREW AFTER PLATE TEMPORARY FIXATION, THE DRILL BIT CHIPPED OFF A COUPLE OF MILLIMETERS. THE SURGEON REMOVED THE BROKEN PIECES. THE IMAGE SHOWED THAT THERE WERE NO PIECES IN THE BODY. ANOTHER DRILL BIT WAS USED FOR SURGERY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THE SURGEON COMMENTED THAT THE DRILL BIT MIGHT INTERFERE WITH THE K-WIRE. THIS REPORT INVOLVES ONE 2.0MM DRILL BIT W/DEPTH MARK QC/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451264 ↗
• MalfunctionDec 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DRILL BIT WAS DULL. IT DOES NOT AFFECT THE PATIENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE FLUTED TIP OF THE DRILL BIT Ø2 W/MARKING L110/85 2FLUTE F/ WAS TWISTED. ADDITIONALLY, ROUNDING OF CUTTING EDGES WAS OBSERVED. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT W/DEPTH MARK QC/110MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311246 ↗
• MalfunctionNov 17, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 A DRILL BIT BROKE WHEN SURGEON TRYING TO USE IT TO DRILL A HOLE IN THE SCAPULAR. SURGEON SAID THE DRILL BIT BROKE BECAUSE OF HIS MANEUVER. SURGEON DECIDED TO LEAVE THE BROKEN PART INSIDE PATIENT, AS HE MENTIONED THAT, TRYING TO REMOVE THE BROKEN PART MAY CAUSE MORE HARM THAN LEAVING IT INSIDE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS WELL. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT W/DEPTH MARK QC/110MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162109 ↗
• MalfunctionOct 9, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A CORRECTIVE OPERATION AFTER PEDIATRIC RADIAL DEFORMITY BONE-UNION WITH DRILL BIT AND TCP PLATE. DURING SURGERY WHEN THE SURGEON WAS DRILLING THE RADIAL DIAPHYSIS, HE PENETRATED THE CONTRALATERAL SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM DRILL BIT W/DEPTH MARK QC/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895977 ↗
• MalfunctionAug 29, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR TARSAL AND METATARSAL FRACTURES WITH DRILL BIT, VA LOCKING DRILL GUIDE, T-FUSION PLATE AND LOCKING SCREW. THE SURGEON USED A T-FUSION PLATE FOR THE PATIENT'S THIRD LISFRANC ARTHRODESIS. THE SURGEON INSERTED A LOCKING SCREW INTO THE PROXIMAL SCREW HOLE AT A FIXED ANGLE. THE SURGEON THEN INSERTED AND DRILLED A FIXED-ANGLE SLEEVE INTO THE NEXT HOLE. DURING THE DRILL, THE SURGEON HEARD SOME INTERFERING NOISES AND STOPPED DRILLING, BUT IMMEDIATELY RESUMED. AS THE DRILL FELT LIGHTER, THE SURGEON THOUGHT IT HAD REACHED THE CONTRALATERAL CORTEX, AND WHEN HE WITHDREW THE DRILL, THE NURSE NOTICED THAT THE DRILL BIT HAD BECOME SHORTER. WHEN THE SURGEON CHECKED THE IMAGE, IT WAS CONFIRMED THAT THE DRILL BIT WAS BROKEN AND ABOUT 1 CM REMAINED IN THE BONE. SINCE SCREWS ARE INSERTED IN OTHER HOLES, AND THE DRILL BIT WAS STILL IN THE BONE, THE SURGEON JUDGED THAT THERE WOULD BE NO STIMULATION TO THE SOFT TISSUE AFTER THE SURGERY, AND DECIDED TO REMAIN IT AS IS. THE SURGEON THEN CLOSED THE WOUND WITHOUT INSERTING THE SCREW INTO THE HOLE WITH THE BROKEN TIP.

  Patient problems: Insufficient Information

  MAUDE report 17641617 ↗
• InjuryAug 1, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON MARCH 24, 2023, THE 2.0MM DRILL FROM A SMALL FRAGMENT INSTRUMENT TRAY BROKE INSIDE THE PATIENT. THE FRAGMENT WAS UNABLE TO BE REMOVED AND WAS LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN MINUTE DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A 2.0MM DRILL BIT W/DEPTH MARK QC/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17437893 ↗