NA 03.130.302Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10886982075598), received between Sep 13, 2017 and Jun 30, 2026 — classified as 12 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT WHEN DRILLING THE DRILL BIT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664924 ↗
• MalfunctionJun 9, 2026Break; Entrapment of Device

  DURING THE PROCEDURE, THE SPECIALIST ASKED TO USE A 1.5 MM DRILL BIT FOR THE 2.0 MM SYSTEM. AFTER PERFORMING MANUAL DRILLING WITHOUT USING THE MOTOR FOR A FEW MINUTES, THE DRILL BIT HAD BROKEN. THE TIP REMAINED INSIDE THE PATIENT AND IT COULDN'T BE REMOVED. ALMOST A CENTIMETER OF THE DRILL BIT TIP REMAINED INSIDE THE PATIENT BECAUSE IT COULDN'T BE REMOVED. THE SPECIALIST EXPLAINED THAT THE DRILL BITS WERE NOT NEW BUT HAD BEEN USED. THE SURGERY WAS DELAYED BY APPROXIMATELY TEN MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 25445491 ↗
• MalfunctionMar 19, 2026Failure to Cut

  IT WAS REPORTED THAT DRILL BIT Ø1.5 L88/57 F/CORE HOLE, 1.5 DRILL BIT/MQC FOR THREADED HOLE/74, 2.0 DB/K-WIRE ATTCHMT GLIDING HOLE/71, AND DRILL BIT Ø2 L57/41 F/GLIDING HOLE WERE DULL AND NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY DURING SURGERY. THESE COMPONENTS WERE DEEMED NON-FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED, WITH REPLACEMENTS REQUIRED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639304 ↗
• MalfunctionMar 19, 2026Failure to Cut

  IT WAS REPORTED THAT DRILL BIT Ø1.5 L88/57 F/CORE HOLE, 1.5 DRILL BIT/MQC FOR THREADED HOLE/74, 2.0 DB/K-WIRE ATTCHMT GLIDING HOLE/71, AND DRILL BIT Ø2 L57/41 F/GLIDING HOLE WERE DULL AND NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY DURING SURGERY. THESE COMPONENTS WERE DEEMED NON-FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED, WITH REPLACEMENTS REQUIRED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639302 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THE 1.5 MM DRILL BIT 1 BROKE IN SITU. BROKEN FRAGMENT COULD BE REMOVED OUT OF THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604906 ↗
• MalfunctionJan 15, 2026Break; Entrapment of Device

  IT WAS REPORTED THE DRILL BIT BROKE INTRAOPERATIVELY. THE TIP OF THE DRILL BIT BECAME EMBEDDED IN THE PATIENT'S BONE AND COULD NOT BE REMOVED, SO THE FRAGMENT WAS INTENTIONALLY LEFT IN PLACE. THE REMAINING PORTION OF THE DRILL BIT WAS REMOVED, AND ANOTHER DRILL BIT OF THE SAME SPECIFICATIONS WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY OR OTHER IMPACT ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24082777 ↗
• MalfunctionDec 22, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING SURGERY ON (B)(6) 2025, THE DRILL BIT BROKE WHILE PLACING THE PLATE. THE TIP OF THE DRILL BIT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23868526 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT 03.130.302 1.5 MM DRILL BIT TIP BROKE OFF DURING USE BY SURGEON. ANKLE FRACTURE SURGERY SUCCESSFULLY COMPLETED. NOTED INCIDENT AND PROVIDE ANOTHER DRILL BIT TO COMPLETE SURGERY. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533572 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT AS INDICATED BY INSTRUMENTATOR, A HAND PIECE OF THE INSTITUTION WAS USED, APPARENTLY IT HAS A LOT OF POWER AND THE BITS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644725 ↗
• MalfunctionMay 5, 2025Break; Break

  DURING THE SURGICAL PROCEDURE, A DRILL BIT WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 21960097 ↗
• MalfunctionFeb 10, 2025Break; Entrapment of Device; Break; Entrapment of Device

  DURING THE PROCEDURE, WHEN PASSING THE 1.5 L74/57 P/HOLE-CORE DRILL BIT TO PLACE THE FIRST SCREW, DESPITE THE FACT THAT THE DRILL BIT WAS BEING IRRIGATED WITH SOLUTION, IT BROKE. THE FRAGMENTS WERE THEN REMOVED AND IT WAS EVIDENT THAT A PART OF THE DRILL BIT REMAINED INSIDE THE PATIENT'S BONE. THE REMOVAL OF SAID FRAGMENT WAS EVALUATED WITH THE SPECIALIST AND ITS EXTRACTION WAS NOT POSSIBLE, WHICH IS WHY IT WAS DECIDED TO LEAVE THIS FRAGMENT INSIDE THE PATIENT'S BONE SINCE IT WOULD NOT CAUSE ANY ADDITIONAL DAMAGE. A DRILL BIT WITH THE SAME CHARACTERISTICS WAS PASSED TO THE SPECIALIST TO CONTINUE WITH THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: Foreign Body In Patient

  MAUDE report 21348090 ↗
• MalfunctionJan 8, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY A 1.5 DRILL BIT FROM THE VA HAND SET TO DRILL A TIBIA SHAFT AND THE DRILLS WERE DESTROYED, LEAVING METAL PARTS IN THE PATIENT BODY. METAL FRAGMENTS WERE COLLECTED; HOWEVER, ONE FRAGMENT REMAINS IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PATIENT WAS TREATED AS PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21105269 ↗
• MalfunctionJan 8, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY A 1.5 DRILL BIT FROM THE VA HAND SET TO DRILL A TIBIA SHAFT AND THE DRILLS WERE DESTROYED, LEAVING METAL PARTS IN THE PATIENT BODY. METAL FRAGMENTS WERE COLLECTED; HOWEVER, ONE FRAGMENT REMAINS IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PATIENT WAS TREATED AS PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21105184 ↗
• MalfunctionDec 9, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL BIT IS BROKEN. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879066 ↗
• MalfunctionOct 30, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A 1.5MM DRILL BIT BROKE INTRA-OPERATIVELY AND LEFT IN PATIENT'S BONE. THE BROKEN FRAGMENTS COULD NOT BE REMOVED AS IT IS STUCK INSIDE PATIENT BONE. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED FOR A MINUTE DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20568436 ↗
• MalfunctionOct 30, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A 1.5MM DRILL BIT BROKE INTRA-OPERATIVELY AND LEFT IN PATIENT'S BONE. THE BROKEN FRAGMENTS COULD NOT BE REMOVED AS IT IS STUCK INSIDE PATIENT BONE. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED FOR A MINUTE DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20568420 ↗
• MalfunctionAug 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2024, WHEN THE SURGEON WAS DRILLING THE BONE, THE DRILL BITS ARE BROKEN AND REMAINED IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT IMPACT. THE CX WAS COMPLETED WITHOUT ANY SETBACKS. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20067486 ↗
• MalfunctionAug 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JULY 18, 2024, WHILE SETTING UP FOR THE CASE THE SCRUB NURSE ATTEMPTED TO ASSEMBLE THE DRILL BIT THROUGH THE DRILL SLEEVE BUT IT WOULD NOT GO THROUGH. THE DRILL GUIDE IS FINE AS IT WORKED FINE WITH ALTERNATE DRILL BITS. THE DRILL BIT FROM LOANER SET DISCARDED TO ENSURE IT IS NOT REUSED. THERE WAS NO SURGICAL DELAY. A DRILL BIT FROM AN ALTERNATIVE SET WAS USED. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992645 ↗
• MalfunctionJun 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE 1.5MM DRILL BIT FROM THE VA HAND SET WAS BROKEN. IT BROKE INTO TWO PIECES, AND AROUND 1CM OF THE BROKEN DRILL BIT WAS LEFT INSIDE THE PATIENT¿S BONE AND COULD NOT BE RETRIEVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, AND THE PATIENT STATUS WAS REPORTED TO BE NORMAL. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19458557 ↗
• MalfunctionMar 1, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN MALAYSIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, A 1.5MM DRILL BIT BROKE DURING THE PROCEDURE. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18818105 ↗
• MalfunctionFeb 21, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THE DRILL BIT BREAKAGE NOT RECOVERED. NO MIGRATION OF THE BROKEN WICK FOR THE MOMENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18753830 ↗
• MalfunctionFeb 1, 2024Break; Break

  THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY.

  Patient problems: Insufficient Information

  MAUDE report 18621664 ↗
• MalfunctionNov 27, 2023Break; Break

  THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212409 ↗
• MalfunctionAug 30, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO 1.5MM DRILL BITS BROKE DURING THE PROCEDURE. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652095 ↗
• MalfunctionJul 19, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT LOAN ORTHOKIT ARRIVED TO LOCAL DISTRIBUTION CENTER (DC) WITH A BROKEN DRILL BIT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17354739 ↗