NA 323.36Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886982190826), received between Aug 28, 2018 and Sep 29, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935009 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT THE SPRING WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 24517988 ↗
• MalfunctionJan 6, 2026Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973270 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THREE ITEMS WERE BROKEN AND NEED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896616 ↗
• MalfunctionJul 25, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DRILL SLEEVE STUCK IN THREADED NIPPLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610130 ↗
• MalfunctionDec 9, 2024Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN DRILL GUIDES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880737 ↗
• MalfunctionMay 16, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024 BEFORE AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE PROCEDURE STARTED IT WAS IDENTIFIED BY SCRUB TECH THAT A 2.5 DRILL BIT COULD NOT BE ADVANCED INTO A 2.5/3.5 DRILL GUIDE. A 2.5 DRILL BIT WAS GETTING STUCK. THE 3.5 DRILL GUIDE WAS BENT FROM THE PLUNGER GUIDE. TRIED THE DRILL BIT TO OTHER DRILL GUIDE AND THERE WAS NO ISSUE. A DIFFERENT DRILL BIT INTO THE FAULTY DRILL GUIDE WAS TRIED AND DRILL BIT COULD NOT BE ADVANCED. IT WAS IDENTIFIED THAT THE TIP OF DRILL GUIDE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19334543 ↗
• MalfunctionAug 31, 2023Use of Device Problem; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING THE SURGERY THE TECH NOTICED THE INSERTS OF A DRILL GUIDE AND THE SPRINGS WERE MIXED AND MISSING. SALES REP WILL WORK WITH THE STERILE PROCESSING DEPARTMENT TO ENSURE THE GETS CORRECTED IN THE NEAR FUTURE. THEY WILL NEED TO ORDER COMPONENTS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO KNOWN ADVERSE EVENTS OCCURRED TO THE PATIENT. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664682 ↗
• MalfunctionAug 31, 2023Use of Device Problem; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Manufacturing, Packaging or Shipping Problem

  PATIENT OUTCOME WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664680 ↗
• MalfunctionMar 28, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE WITH MINI QUICK COUPLING WAS TAGGED AS BROKEN BY THE STERILE PROCESSING DEPARTMENT. THE HANDLE KEEPS STICKING TO THE SCREWDRIVER SHAFTS AND THE SCREWDRIVER SHAFTS KEEP GETTING STUCK ON THE HANDLE. UNIVERSAL DRILL GUIDE WAS TAGGED BEING BROKE, THE TEETH ON THE 3.5MM DRILL GUIDE SIDE HAVE FLARED OUT, AND LOOK AS IT MAY BREAK OFF. THE JAWS OF THE PLIERS NO LONGER COME TOGETHER, THERE IS APPROXIMATELY 1MM GAP. THE ITEMS WERE MARKED AS NEEDING REPAIR AFTER UNKNOWN CASES. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631950 ↗
• MalfunctionDec 15, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL GUIDE IN QUESTION WAS FOUND TO HAVE BENT AND NO LONGER ALLOWS FOR THE DRILL BIT TO PASS THROUGH. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986605 ↗
• MalfunctionMay 3, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE 3.5MM UNIVERSAL DRILL GUIDE WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT TEETH ON BOTH ENDS ARE BENT AND DEFORMED. THIS REPORT IS FOR A 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269802 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET, IT WAS OBSERVED THAT THE 3.5MM UNIVERSAL DRILL GUIDE WAS BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755113 ↗
• MalfunctionNov 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION,IT WAS DISCOVERED THAT THE UNIVERSAL DRILL GUIDE WAS NON-FUNCTIONAL. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728607 ↗
• MalfunctionSep 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION, A SMALL SCREW WAS FOUND LOCATED ON THE BACK OF THE COMPRESSION/DISTRACTION INSTRUMENT KEEPS LOOSENING AND COMING OFF AND THE UNIVERSAL DRILL GUIDE INSERT WON'T COME OUT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470223 ↗
• MalfunctionJul 29, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEPTH GAUGE PRONG IS BROKEN AND THE DRILL GUIDE TUBE IS BENT AND THE 2.5MM DRILL BIT WILL NOT PASS THROUGH IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR (1) 3.5MM UNIVERSAL DRILL GUIDE . THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249600 ↗
• MalfunctionNov 12, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 3.5 MM UNIVERSAL DRILL GUIDE WAS BENT. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10829389 ↗
• MalfunctionOct 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SCREWDRIVER T15 HEAD STRIPPED, STARDRIVE SCREWDRIVER SHAFT T8 HEAD STRIPPED, STARDRIVE SCREWDRIVER SHAFT SELF-RETAINING HEAD STRIPPED, RATCHETING HANDLE WITH QUICK COUPLING DID NOT WORK, DEPTH GAUGE BROKE, 2.7MM DRILL GUIDE WAS BENT, 3.5MM DRILL GUIDE WAS BENT, DEPTH GAUGE WAS BENT ON THE TIP, INSERTER-EXTRACTOR IS BENT, DEPTH GAUGE BROKE OFF. THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665081 ↗
• MalfunctionSep 16, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE UNIVERSAL DRILL GUIDE BROKE INTO TWO PIECES DURING A SURGICAL PROCEDURE. THE BROKEN PIECES WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540865 ↗
• MalfunctionFeb 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN USING THE THERE'S A 3.5MM UNIVERSAL DRILL GUIDE AND AN UNKNOWN DRILL BITS. THE DRILL BIT SIDE GOES A HALF WAY THROUGH AND THEN STOPS. THE PART WAS CLEANED TO MAKE SURE IT IS THE RIGHT INNER SLEEVE AND THEN ALL APPEARS TO BE CORRECT YET FOR SOME REASON, IT IS NOT WORKING. IT IS UNKNOWN WHERE THE ISSUE WAS DISCOVERED. PROCEDURE AND PATIENT INVOLVEMENT WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763268 ↗
• MalfunctionFeb 19, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET A DRILL GUIDE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 3.5MM UNIVERSAL DRILL GUIDE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9726384 ↗
• MalfunctionNov 12, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A UNIVERSAL DRILL GUIDE WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311523 ↗
• MalfunctionOct 29, 2019Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE , THE TWO (2) UNIVERSAL DRILL GUIDE WERE DEFECTIVE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9253170 ↗
• MalfunctionOct 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: 3.5 MM LC-DCP DRILL GUIDE NEUTRAL AND LOAD SPRING LADED BALL CAME OFF DURING REGULAR CLEANING PROCESS. IN ADDITION, THE 3.5 MM UNIVERSAL DRILL GUIDE: DEFECTIVE SPRING-LOADED END MAKES THE ENTIRE UNIVERSAL DRILL GUIDE DEFECTIVE. NO PATIENT INVOLVEMENT. THIS IS REPORT FOR 01 OF 01 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203982 ↗
• MalfunctionOct 9, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE UNIVERSAL DRILL GUIDE WAS MISSING A PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 3.5 MM UNIVERSAL DRILL GUIDE. THIS IS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9171794 ↗