NA 03.113.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982072894), received between Jan 8, 2018 and Apr 7, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Break; Entrapment of Device

  DURING THE PROCEDURE, WHILE THE DOCTOR WAS PERFORMING THE DRILLING USING A CALIBRATED, STOPPED 2.5 MM DIAMETER DRILL BIT (LENGTH 250/225 MM, QUICK-COUPLING), THE BIT FRACTURED, LEAVING A SMALL FRAGMENT EMBEDDED WITHIN THE PATIENT'S BONE. THE DOCTOR ATTEMPTED TO RETRIEVE THE FRAGMENT BUT WAS UNABLE TO DO SO; CONSEQUENTLY, HE DECIDED TO LEAVE THE TIP IN PLACE, CITING THE DIFFICULTY OF EXTRACTION AND THE FACT THAT LEAVING IT WITHIN THE BONE WOULD POSE NO ISSUES. THE SITUATION WAS RESOLVED BY REMOVING THE REMAINDER OF THE FRACTURED DRILL BIT AND INSERTING A REPLACEMENT BIT WITH IDENTICAL SPECIFICATIONS, WHICH WAS ALSO INCLUDED IN THE SURGICAL KIT. THE INCIDENT CAUSED NO DISRUPTION TO THE SPECIALIST. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DEVIATION FROM THE SCHEDULED SURGICAL TIMELINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24800215 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT HAD BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320486 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT HAD BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320459 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT HAD BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320366 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT HAD BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320342 ↗
• MalfunctionJan 14, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A DRILL BIT BROKE DURING THE PROCEDURE, A FRAGMENT OF THE DRILL BIT REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21148795 ↗
• MalfunctionSep 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRILL BIT WAS BROKEN. NO FURTHER DETAILS WERE PROVIDED. IT IS UNKNOWN WHEN THE BREAKAGE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 20279432 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024 A DRILL BIT WAS BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT A SCREW. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE. NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195676 ↗
• MalfunctionApr 5, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT UNKNOWN SURGERY WITH A PHILOS MIPO DEVICE. WHILE PERFORMING INTERNAL FIXATION, IN A DRILL SLEEVE, DRILL BIT BROKE OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN EXTRA 30 MINUTES. POSTOPERATIVE X-RAY CONFIRMED THERE WAS NO RESIDUE IN PATIENT¿S BODY. ACCORDING TO OPERATOR, THE DRILL WAS PULLED OFF TOWARD STANDARD ROTATION DEPENDING ON IT TOOK EXTRA FORCE, ACCORDINGLY ITS BIT WAS LIKELY STUCK IN SLIT IN SLEEVE, SO THE CONDITIONS LIKELY WAS BLAME. THE PATIENT STATUS/ OUTCOME WAS REPORTED AS STABLE. OUR SALES REP CONVINCED THE GRIEVANCE WHICH STEMMED FROM SURGEON¿S POOR TECHNIQUE. ADDITIONALLY, BROKEN BIT WAS REPORTED AS STILL TIGHTLY GETS STUCK IN SLEEVE, AND TAKING IT AWAY APPEARED TO BE HARD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)DRILL BIT Ø2.5 W/STOP CALIBR L250/225 F/ THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 19055323 ↗
• MalfunctionDec 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON NOVEMBER 10, 2023, THAT THE DRILL WAS BROKEN. GENERATES A DELAY OF 2 MINUTES IN THE PROCEDURE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.5 W/STOP CALIBR L250/225 F/ THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18250275 ↗
• MalfunctionJul 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON JULY 24, 2023, THE DRILL BIT BROKE WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413647 ↗
• MalfunctionJul 18, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION BENT AFTER CONTACTING THE LATERAL TIBIAL CORTEX. THE CASE WAS UNABLE TO SEPARATE FROM THE ACTUAL LENGTH OF THE DRILL BIT, AND THE PATIENT WAS NOT ABLE TO PASS THROUGH THE DRILL GUIDE. THE TIP OF THE DRILL BIT NEEDED TO BE CUT OFF, NO FRAGMENTS REMAIN IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT DRILL BIT OF THE SAME TYPE. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341592 ↗
• MalfunctionJul 11, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS:IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHILE MANIPULATING THE 3.2 DRILL BIT OF THE 3.5VA PROXIMAL TIBIA SYSTEM, THE BIT BROKE AT ITS TIP. THE FRAGMENT GENERATED WAS EASILY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE.THIS REPORT IS FOR A 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299009 ↗
• MalfunctionApr 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THE DRILL BIT BROKE DURING THE SURGICAL PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.5 W/STOP CALIBR L250/225 F/. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809097 ↗
• MalfunctionApr 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON (B)(6) 2022. THERE WAS NO ALLEGATION REPORTED AGAINST THE DEVICE. UPON PRODUCT RETURN AND INVESTIGATION ON (B)(6) 2023, IT WAS FOUND THAT THE ITEM WAS BROKEN FROM THE DISTAL TIP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708713 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) OF 2023, THE DRILL BIT IN QUESTION WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378643 ↗
• InjuryNov 9, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ORTHOPEDIC SURGERY, A SMALL PIECE OF A DRILL BIT BROKE OFF IN THE BONE AND WAS UNABLE TO BE RETRIEVED. THE DRILL BIT PIECE WAS LEFT IN THE BONE. THIS REPORT IS FOR A 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15763810 ↗
• InjuryNov 9, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ORTHOPEDIC SURGERY, A SMALL PIECE OF A DRILL BIT BROKE OFF IN THE BONE AND WAS UNABLE TO BE RETRIEVED. THE DRILL BIT PIECE WAS LEFT IN THE BONE. THIS REPORT IS FOR A 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15762730 ↗
• InjuryMar 29, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT IS BROKEN, LEAVING A FRAGMENT INSIDE THE PATIENT, THE DR. INFORMS US THAT IT IS NOT NECESSARY TO REMOVE IT. WITH PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE DRILL BIT Ø2.5 W/STOP CALIBR L250/225. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13938270 ↗
• MalfunctionMar 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022. DURING THE PROCEDURE, THE DRILL BIT WAS BROKEN, LEAVING A FRAGMENT INSIDE THE PATIENT. THIS REPORT IS FOR ONE (1) 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13901138 ↗
• MalfunctionNov 29, 2021Break; Break

  THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12887739 ↗
• MalfunctionJun 18, 2021Overheating of Device; Failure to Cut; Overheating of Device; Failure to Cut

  IT WAS REPORTED ON AN UNKNOWN PROCEDURE THAT LOCKING SCREW DID NOT ENGAGE WITH ONE OF THE COMBO HOLES IN THE PLATE. A NON-LOCKING SCREW WAS USED IN ITS PLACE. THE LOCKING SCREW WAS FOUND NOT BE THE PROBLEM AS THE SAME SCREW ENGAGED A DIFFERENT LOCKING HOLE. TWO NEW DRILL BITS WERE ALSO FOUND TO BE DULL AND HEATED UP THE BONE EXCESSIVELY WHEN TRYING TO DRILL WITH THEM. NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES 3 DEVICE. THIS REPORT IS FOR ONE (1) 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029008 ↗
• MalfunctionMay 10, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 DURING A PROCEDURE, WHEN DRILLING A NEW HOLE WITH THE 2.5 DRILL BIT, IT COLLIDED WITH ONE OF THE IMPLANTS THAT THE PATIENT ALREADY HAD AND CAUSED IT TO BEND AT THE TIP. CONCOMITANT DEVICES: UNKNOWN PLATES (PART# UNKNOWN;LOT# UNKNOWN; QUANTITY: 1). UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802289 ↗
• MalfunctionFeb 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED DURING A TIBIA PLATEAU PROCEDURE, THE SCRUB TECHNICIAN COULD NOT INSERT THE DRILL BIT INTO THE QUICK COUPLING OF THE DRILL. AFTER A FEW MINUTES OF TRYING, A NEW ONE WAS USED. THERE WAS A SURGICAL DELAY OF A FEW MINUTES REPORTED. THE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8312944 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN SURGERY, WHILE DRILLING ONE (1) CALIBRATED DRILL BIT AND ONE (1) THREE-FLUTED DRILL BIT WERE BROKEN. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.5MM CALIBRATED DRILL BIT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092523 ↗