NA 03.133.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886982269928), received between Sep 11, 2020 and May 13, 2026 — classified as 30 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2026, THE DRILL WOULD NOT COME OUT OF DRILL GUIDE. IT APPEARED THE DRILL GUIDE WAS BENT DURING INSERTION OF SCREWS. ANOTHER SET WAS OPENED AND A DRILL BIT AND DRILL GUIDE WERE USED TO COMPLETE THE CASE. THE SURGERY WAS DELAYED BY FOUR MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164540 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT A DRILL GUIDE BROKE DURING WASHING IN A WASHING MACHINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112990 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL BIT STUCK INSIDE DRILL GUIDE, STAFF UNABLE TO REMOVE, AND IT WAS UNSAFE TO KEEP TRYING TO REMOVE AS IT IS A SHARP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560993 ↗
• MalfunctionJan 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER PERFORMING THE INTERFRAGMENTARY COMPRESSION, THE DRILL BIT BECAME STUCK IN ITS GUIDE AND COULD NOT BE REMOVED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT AFFECTING THE PATIENT OR ALTERING THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024161 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE DAY BEFORE THE SURGERY, THE PRODUCTS IN QUESTION WERE CLEANED BEFORE STERILIZATION. JUST BEFORE THE STERILIZATION, A STAFF FROM THE CENTRAL STERILE SUPPLY DEPARTMENT FOUND THAT THE PAINT (BLACK AND ORANGE) ON THE PRODUCTS IN QUESTION WAS PEELING OFF. BECAUSE THE PAINT PEELED OFF EASILY WHEN THE PRODUCTS WERE TOUCHED, THE REPLACEMENTS WERE ARRANGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524029 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SCRUB TECH USED THE GUIDE TO BEND ANOTHER INSTRUMENT AND BROKE THE DRILL GUIDE. THE INCIDENT DID NOT OCCUR DURING STERILE PROCESSING, CALIBRATION, OR FIELD INSPECTION. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23340187 ↗
• MalfunctionMay 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DRILL GUIDE WAS FOUND BENT POST-OPERATIVELY IN STERILIZATION UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961176 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDE WAS BROKEN DURING SURGICAL PROCEDURE. FRAGMENTS GENERATED. PATIENT WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170582 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE NON-LOCKING DRILL GUIDE 3.5 MM FROM THE LOAN SET WAS DELIVERED DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939259 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT INVOLVES ONE 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 8 OF 9 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4) AND (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689299 ↗
• MalfunctionMay 16, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THERE WAS A BROKEN DRILL GUIDE. NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336827 ↗
• MalfunctionJan 3, 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 GUIDE IN QUESTION FOR A HUMERAL PROXIMAL FRACTURE. THE SURGEON HELD THE DRILL GUIDE THROUGH THE POWER TOOL AND THE DRILL BIT WITH ONE HAND. THE SURGEON GRIPPED IT SO HARD THAT THE DRILL GUIDE WAS OVERLOAD AND BROKE OFF. ANOTHER DRILL GUIDE WAS USED FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON CONFIRMED THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THIS REPORT INVOLVES ONE 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434356 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2023, THE GUIDE WAS BROKEN IN CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY TO RETRIEVE NEW SET. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT CONSEQUENCE WAS REPORTED. PATIENT OUTCOME IS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) 3.5MM NON-LOCKING DRILL GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360858 ↗
• MalfunctionDec 11, 2023Device-Device Incompatibility; Noise, Audible; Device-Device Incompatibility; Noise, Audible

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 17-NOVEMBER-2023, THE PATIENT UNDERWENT ORIF WITH THE PRODUCT IN QUESTION FOR A TIBIAL DISTAL FRACTURE. WHEN DRILLING WAS ATTEMPTED WITH THE BIT AND SLEEVE, A GRINDING SOUND OCCURRED. THE DRILL BIT BECAME STUCK IN THE SLEEVE AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING ANOTHER DRILL BIT AND DRILL SLEEVE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302018 ↗
• MalfunctionOct 5, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT BROKE INTRAOPERATIVELY. THERE WAS NO FORCE EXERTED. THIS REPORT INVOLVES ONE (1) 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17875384 ↗
• MalfunctionOct 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT BROKE INTRAOPERATIVELY. THERE WAS NO FORCE EXERTED. THIS REPORT INVOLVES ONE (1) 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17870735 ↗
• MalfunctionSep 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT BECAME JAMMED INSIDE OF THE DRILL GUIDE. SURGERY WAS DELAYED FOR APPROXIMATELY 2 MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT DRILL BIT. NO FRAGMENTS WERE GENERATED. THERE WAS NO ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694182 ↗
• MalfunctionJun 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ITEMS BROKE WHILE BEING USED. THIS REPORT INVOLVES ONE (1) 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133888 ↗
• MalfunctionMay 10, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A MATERIAL DEFECT. PATIENT OUTCOMES AND CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT NON-LOCKING DRILL GUIDE 3.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903425 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL GUIDE WAS DROPPED AND IT BROKE IN HALF. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON THE PATIENT. THIS REPORT IS FOR ONE (1) NON-LOCKING DRILL GUIDE 3.5 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690380 ↗
• MalfunctionNov 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL GUIDE WAS BROKEN. THERE WAS NO DELAY IN SURGERY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770192 ↗
• MalfunctionJun 22, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE TRAY WAS OPENED FOR SURGERY AND THE DRILL GUIDE WAS FOUND BROKEN SO MAY HAVE OCCURRED IN STERILE SERVICES. THIS COMPLAINT INVOLVES ONE(1) DEVICE NON-LOCKING DRILL GUIDE 3.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775292 ↗
• MalfunctionMay 9, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, ITEM WAS SHIPPED WITH THE NEW PPFX SYSTEM AND IT ARRIVED BROKEN. THIS COMPLAINT INVOLVES ONE DEVICE 3.5MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336885 ↗
• MalfunctionFeb 9, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A ORIF OF ANKLE PROCEDURE ON (B)(6), 2022 WHEN SURGEON WAS DRILLING THROUGH THE DRILL GUIDE INTO A 1/3 TUBULAR PLATE WITH THE 2.5MM GOLD DRILL BIT, THE GUIDE SNAPPED AT THE END. THE PROCEDURE WAS DELAYED FOR TWO (2) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DRILL GUIDE. THIS REPORT IS FOR ONE (1) 3.5MM NON-LOCKING DRILL GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501926 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE NON-LOCKING DRILL GUIDE WAS FOUND BROKEN AFTER RESET THE TRAYS. THE STERILE PROCESSING DEPARTMENT FOUND TWO (2) PIECES IN A CASKET IN THE WASH. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) NON-LOCKING DRILL GUIDE 3.5 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190593 ↗