NA 310.23Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10886982186263), received between Aug 8, 2017 and Apr 9, 2026 — classified as 21 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Break; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT A 2.5MM DRILL BIT/QC/GOLD/180MM BROKE DURING SURGERY, RESULTING IN A FRAGMENT OF THE DRILL BIT REMAINING EMBEDDED IN THE PATIENT'S BONE. THE PATIENT RETAINED THE DRILL BIT PIECE IN THE SHOULDER, AND THE RISK OF REMOVAL WAS DETERMINED TO OUTWEIGH THE BENEFIT. THERE WAS NO SURGICAL DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REMAINING PORTION OF THE DRILL BIT WAS SECURED AT THE FACILITY AND IS NOT AVAILABLE FOR RETURN. ALL OTHER DRILL BITS OF THE SAME TYPE WERE REMOVED FROM SERVICE AT THE FACILITY, AND A SINGLE-USE ALTERNATIVE IS NOW IN USE. THE STATUS OF THE COMPLAINT DEVICE IS THAT IT REMAINS EMBEDDED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24828934 ↗
• MalfunctionApr 6, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT BROKEN DRILL 2.5 DRILL BIT LEFT IN PATIENT HUMERUS. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24788726 ↗
• MalfunctionFeb 20, 2026Contamination /Decontamination Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SURGEON COMPLAINS ABOUT LONG 2.5 DRILL BIT, LEAVING A BLACK MUD COLOR LIKE SUBSTANCE IN PATIENT AFTER DRILLING. USUALLY HAPPENS WHEN DRILLING IN 2.5/3.5 UNIVERSAL TISSUE PROTECTOR, BUT ALSO HAPPENS WITHOUT TISSUE PROTECTOR. HAPPENS REGARDLESS OF DRILLING THROUGH A PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401913 ↗
• MalfunctionNov 13, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON ON OCTOBER 26, 2025, THERE WAS A BROKEN DRILL AT LEVEL OF FLUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 23546301 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS OBSERVED THAT THE REFERENCE MATERIAL BROKE, WHICH IS WHY IT CAN NO LONGER BE USED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414795 ↗
• MalfunctionSep 23, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SURGEON MENTIONED RECENTLY THAT WHEN HE IS USING THE DRILL BIT, IT IS LEAVING A BLACK RESIDUE. HE HAS NOTICED IT MULTIPLE TIMES NOW. IT DOES NOT APPEAR TO HAPPEN WITH THE SHORTER DRILL BIT. WHEN HE CLEANS THE DRILL BIT, PASSES IT THROUGH A TISSUE PROTECTOR, A BUNCH OF BLACK DEBRIS COMES OFF. THE SURGERY WAS NOT DELAYED. TO CONTINUE THE SURGERY ANOTHER DRILL BIT WAS USED. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE ADDITIONAL EVENTS THAT HAVE HAPPENED IN THE PAST.

  Patient problems: Insufficient Information

  MAUDE report 20281988 ↗
• MalfunctionSep 23, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SURGEON MENTIONED RECENTLY THAT WHEN HE IS USING THE DRILL BIT (2.5MM DRILL BIT/QC/GOLD/180MM) IT WAS LEAVING A BLACK RESIDUE. THE SURGEON HAS NOTICED IT MULTIPLE TIMES NOW AND IS CONCERNED. IT DOES NOT APPEAR TO HAPPEN WITH THE OTHER DRILL BITS (2.5MM DRILL BIT/QC/GOLD/110MM). THE SURGEON CLEANS THE DRILL BIT, PASSES IT THROUGH A TISSUE PROTECTOR THEN A BUNCH OF BLACK DEBRIS COMES OFF. THIS (B)(4) IS RELATED WITH THIS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20280908 ↗
• MalfunctionSep 10, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SURGEON MENTIONED RECENTLY THAT WHEN HE IS USING THE DRILL BIT, IT IS LEAVING A BLACK RESIDUE. HE HAS NOTICED IT MULTIPLE TIMES NOW. IT DOES NOT APPEAR TO HAPPEN WITH THE SHORTER DRILL BIT. WHEN HE CLEANS THE DRILL BIT, PASSES IT THROUGH A TISSUE PROTECTOR, A BUNCH OF BLACK DEBRIS COMES OFF. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE ADDITIONAL EVENTS THAT HAVE HAPPENED IN THE PAST.

  Patient problems: Insufficient Information

  MAUDE report 20180354 ↗
• MalfunctionSep 6, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A SURGEON MENTIONED THAT A BLACK RESIDUE WAS BEING LEFT DURING THE 2.5MM DRILL BIT USE DURING PROCEDURE. IT WAS NOTICED MULTIPLE TIMES NOW. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20160366 ↗
• MalfunctionFeb 7, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024 WHILE DOING A PROXIMAL THE SURGEON DRILLED INTO BONE FOR A SCREW AND WHEN HE PULLED THE DRILL OUT OF THE BONE HE NOTICED THAT PART OF THE DRILL TIP WAS MISSING. THE SURGEON TRIED TO REMOVE THE TIP, BUT WAS UNABLE TO ATTAIN IT. PROCEDURE COMPLETED SUCCESSFULLY . THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/180MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18660686 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT IN QUESTION SNAPPED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293228 ↗
• MalfunctionOct 26, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR A REDUCTION OF A FRACTURE IN TIBIA AND FIBULA. WHEN DRILLING FOR THE 3.5MM CORTICAL SCREW IN THE MEDIAL PLATE OF THE TIBIA, THE DRILL BIT IN QUESTION BROKE. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18013606 ↗
• MalfunctionOct 6, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SURGERY THE WICK OF THE ITEM IN QUESTION BROKE. THE DISTAL PORTION REMAINED IN THE SURGICAL SITE, THE LEFT DISTAL HUMERUS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17888208 ↗
• InjuryJul 27, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL 2.5MM BIT BROKE DURING DRILLING. THE NEAR SHAFT WAS REMOVED AND THE FAR SHAFT RETAINED IN THE BONE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE 2.5MM DRILL BIT/QC/GOLD/180MM FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17405446 ↗
• MalfunctionApr 4, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 16-MARCH-2023, THE DRILL BIT WAS FOUND TO BE BROKEN WHEN THE MATERIAL WAS OPENED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675931 ↗
• InjuryMar 23, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON AN UNKNOWN DATE, A DRILL BIT BROKE DURING THE COURSE OF THE CASE. THE TIP STAYED IN AND THE REST WAS REMOVED FROM THE FIELD. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/180MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16602556 ↗
• MalfunctionSep 1, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE TIP OF THE DRILL BIT IN QUESTION SPLIT. THIS GENERATED A DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335093 ↗
• InjuryApr 28, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE 2.5 MM DRILL BIT WAS BROKEN OFF AND LEFT INSIDE THE PATIENT'S BODY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES (1) DEVICE UNK - DRILL BITS: TRAUMA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14242517 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE TIP OF THE DRILL BIT WAS BROKEN OFF INTO THE TIBIA. THE BROKEN TIP WAS RETAINED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.5MM DRILL BIT/QC/GOLD/180MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12600686 ↗
• InjuryMay 19, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A TIBIAL PLATEAU REVISION DUE TO NON-UNION. LAST NIGHT DURING A TIBIAL PLATEAU REVISION NONUNION CASE, WE WERE DRILLING THROUGH A MEDIAL PROXIMAL TIBIA PLATE, WE WERE DRILLING A 2.5 GOLD DRILL BIT AND WHEN DRILLING, BEFORE WE WOULD PLACE THE SCREW IN, THE TIP OF THE DRILL BIT BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN DETERMINED THAT DRILL BIT WOULD BE LEFT IN THE PATIENT, IT WOULD BE MORE DAMAGE THEN GOOD TO TRY TO GO AND GET IT WHEN THERE IS ALREADY ADDITION AMOUNT OF HARDWARE IN THE PROXIMAL TIBIA. THERE WAS NO CASE DELAY, NO PATIENT HARM, OTHER THAN LEAVING THE DRILL BIT WITHIN THE PATIENT. (B)(6) HOSPITAL WOULD LIKE TO SEE IF THIS PRODUCT NUMBER HAD A HISTORY OF BREAKAGE. CONCOMITANT DEVICE REPORTED: UNKNOWN TIBIAL PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY) UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11852683 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE DRILLING FOR A SCREW THROUGH A PLATE WITHOUT A TISSUE PROTECTOR, THE SURGEON BOUND A DRILL BIT UP AGAINST THE PLATE AND BROKE THE DRILL BIT. FRAGMENTS WERE GENERATED AND WAS EASILY REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY AND NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844897 ↗
• InjuryApr 9, 2021Break; 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) 2021 DURING AN UNKNOWN PROCEDURE, ONE (1) K-WIRE WAS BENT AND ONE (1) DRILL BIT BROKE AND LEFT A FRAGMENT IN THE PATIENT'S TUBE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11642664 ↗
• InjuryDec 21, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY THE TIP OF THE DRILL BIT BROKE OFF IN THE RIGHT ANKLE BONE AND WAS UNABLE TO RETRIEVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT INVOLVES ONE (1) 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11049459 ↗
• InjuryDec 5, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT PELVIC SURGERY. DURING THE PROCEDURE, THE SURGEON WAS USING A LONG 2.5MM DRILL BIT TO DRILL THROUGH THE PUBIC CREST INTO THE ISCHIUM IN ORDER TO PLACE A LONG 3.5MM CORTEX SCREW THROUGH A PLATE INTO THE ISCHIUM ON THE PATIENTS LEFT SIDE. THE FIRST DRILL BIT BROKE AFTER EXTENSIVE USE ABOVE THE NEAR CORTEX AND THE BROKEN PIECE WAS SUCCESSFULLY REMOVED WITH A NEEDLE DRIVER. A SECOND 2.5MM DRILL BIT WAS USED TO PLACE A SIMILAR SCREW ON THE PATIENT'S OTHER SIDE. THAT DRILL BIT ALSO BROKE BUT THE SURGEON DISCERNED THAT IT BROKE OFF TOO FAR INTO THE ISCHIUM TO BE SAFELY REMOVED. THE SURGEON CONTINUED WITH THE SURGERY USING A DIFFERENT DRILL BIT TO COMPLETION. NORMAL INTRA-OPERATIVE X-RAYS WERE TAKEN ON AN UNKNOWN DATE TO DETERMINE SCREW PLACEMENT AROUND THE BROKEN DRILL BIT FRAGMENT. THERE WAS A SURGICAL DELAY OF FIVE (5) TO SEVEN (7) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED (PART# 324.212, LOT# UNKNOWN, QUANTITY 1) UNK- SCREWS: CORTEX: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.5

  Patient problems: Foreign Body In Patient

  MAUDE report 10953617 ↗
• MalfunctionDec 5, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT PELVIC SURGERY. DURING THE PROCEDURE, THE SURGEON WAS USING A LONG 2.5MM DRILL BIT TO DRILL THROUGH THE PUBIC CREST INTO THE ISCHIUM IN ORDER TO PLACE A LONG 3.5MM CORTEX SCREW THROUGH A PLATE INTO THE ISCHIUM ON THE PATIENTS LEFT SIDE. THE FIRST DRILL BIT BROKE AFTER EXTENSIVE USE ABOVE THE NEAR CORTEX AND THE BROKEN PIECE WAS SUCCESSFULLY REMOVED WITH A NEEDLE DRIVER. A SECOND 2.5MM DRILL BIT WAS USED TO PLACE A SIMILAR SCREW ON THE PATIENT'S OTHER SIDE. THAT DRILL BIT ALSO BROKE BUT THE SURGEON DISCERNED THAT IT BROKE OFF TOO FAR INTO THE ISCHIUM TO BE SAFELY REMOVED. THE SURGEON CONTINUED WITH THE SURGERY USING A DIFFERENT DRILL BIT TO COMPLETION. NORMAL INTRA-OPERATIVE X-RAYS WERE TAKEN ON AN UNKNOWN DATE TO DETERMINE SCREW PLACEMENT AROUND THE BROKEN DRILL BIT FRAGMENT. THERE WAS A SURGICAL DELAY OF FIVE (5) TO SEVEN (7) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED (PART# 324.212, LOT# UNKNOWN, QUANTITY 1) UNK- SCREWS: CORTEX: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) 2.5M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10951578 ↗