NA 312.18Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10887587036540), received between Sep 20, 2018 and Nov 18, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (19 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE 1.8MM SIDE OF THE DRILL GUIDE IS WARPED AND WILL NOT ALLOW THE 1.8MM DRILL BIT TO PASS THROUGH IT PROPERLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582779 ↗
• MalfunctionNov 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE 1.8MM SIDE OF THE DRILL GUIDE IS WARPED AND WILL NOT ALLOW THE 1.8MM DRILL BIT TO PASS THROUGH IT PROPERLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582777 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085431 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION OF BEING BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085333 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL GUIDE IS BENT. DRILL BIT DID NOT PASS THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107270 ↗
• MalfunctionSep 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE DOING A LAG SCREW PROCEDURE IN BONE, TWO 2.4/1.8 DRILL GUIDES WERE BENT. ELBOW PLATE HAD A 3.5 LOCKING SCREW THAT DID NOT LOCK INTO PLATE. EX FIX SLEEVE WAS COLD WELDED TO SCHANZ PIN WHILE DRILLING. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251690 ↗
• MalfunctionSep 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE DOING A LAG SCREW PROCEDURE IN BONE, TWO 2.4/1.8 DRILL GUIDES WERE BENT. ELBOW PLATE HAD A 3.5 LOCKING SCREW THAT DID NOT LOCK INTO PLATE. EX FIX SLEEVE WAS COLD WELDED TO SCHANZ PIN WHILE DRILLING. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251618 ↗
• MalfunctionJun 24, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 1.8/2.4 STANDARD DRILL GUIDE WAS BENT WHEN IT WAS USED IN CASE. SURGEON COULD NOT GET THE DRILL BIT TO FIT THROUGH THE GUIDE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.4MM/1.8MM DOUBLE DRILL SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601944 ↗
• MalfunctionApr 11, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE 1.8MM SIDE IS NOT WORKING PROPERLY WITH A DRILL BIT. IT MAY BE BENT. IT WAS NOT IDENTIFIED DURING A SURGERY. SURGEON NOTICED IT WHILE PUTTING SET BACK TOGETHER. THE EVENT WAS DISCOVERED DURING INSPECTION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 2.4MM/1.8MM DOUBLE DRILL SLEEVE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086813 ↗
• MalfunctionDec 6, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE DRILL GUIDE SLEEVE WAS WARPED AND WOULD NOT ALLOW THE DRILL BIT TO PASS THROUGH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ON DELAY USING ANOTHER DRILL GUIDE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275747 ↗
• MalfunctionDec 6, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE DRILL GUIDE SLEEVE WAS WARPED AND WOULD NOT ALLOW THE DRILL BIT TO PASS THROUGH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ON DELAY USING ANOTHER DRILL GUIDE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275745 ↗
• MalfunctionNov 15, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING ROUTINE MEDIAL DEVICE REPROCESSING, STAFF DISCOVERED THAT THE TIP OF THE DRILL SLEEVE IN QUESTION WAS DAMAGED. THE LEADING EDGE OF THE 1.8MM PORTION WAS SLIGHTLY BENT, PREVENTING 1.8MM DRILL BITS FROM PASSING THROUGH SMOOTHLY. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140954 ↗
• MalfunctionSep 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE 1.8 DRILL SLEEVES IN QUESTION WERE FOUND TO BE BENT AND ARE NOT USABLE. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17826441 ↗
• MalfunctionSep 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE 1.8 DRILL SLEEVES IN QUESTION WERE FOUND TO BE BENT AND ARE NOT USABLE. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17826438 ↗
• MalfunctionSep 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE 1.8 DRILL SLEEVES IN QUESTION WERE FOUND TO BE BENT AND ARE NOT USABLE. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17826437 ↗
• MalfunctionSep 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE 1.8 DRILL SLEEVES IN QUESTION WERE FOUND TO BE BENT AND ARE NOT USABLE. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17826433 ↗
• MalfunctionSep 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE 1.8 DRILL SLEEVES IN QUESTION WERE FOUND TO BE BENT AND ARE NOT USABLE. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17826432 ↗
• MalfunctionJun 15, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DRILL SLEEVE WAS BENT UPON ARRIVAL AT HOSPITAL. THERE WAS NO IMPACT TO SURGERY; NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135223 ↗
• MalfunctionJan 5, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE STAFF HAVE INDICATED THAT A FEW INSTRUMENTS REQUIRE REPLACING. THE 2.4MM DRILL BIT HAS SOME BURRS/IMPERFECTIONS AND IS NO LONGER USABLE. THE 2.4/1.8MM DOUBLE DRILL SLEEVE ¿TEETH¿ ON THE ONE END ARE CHIPPED AND NO LONGER IN WORKING CONDITION. THE COUNTERSINK ALSO HAS SOME BURRS ON THE TOP AND REQUIRES REPLACEMENT. THE MINI QUICK COUPLING HANDLE NO LONGER ACCEPTS A QUICK COUPLING ATTACHMENT AND IS THEREFORE ALSO NOT IN WORKING CONDITION. THIS DID NOT OCCUR INTRA OPERATIVELY, SO THERE WERE NO PATIENT ISSUES OR SURGICAL DELAYS. THIS REPORT INVOLVES ONE2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102778 ↗
• MalfunctionJan 4, 2023Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE ¿TEETH¿ ON ONE END OF THE 2.4/1.8MM DOUBLE DRILL SLEEVE ARE CHIPPED, AND THE MINI QUICK COUPLING HANDLE NO LONGER ACCEPTS A QUICK COUPLING ATTACHMENT. NEITHER ARE IN WORKING CONDITION. THIS EVENT DID NOT OCCUR INTRA OP, THERE ARE NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094282 ↗
• MalfunctionMay 3, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP ON THE DRILL GUIDE DEVICE WAS BROKEN DURING COMPRESSION. IT WAS UNKNOWN WHETHER THE SURGERY WAS COMPLETED SUCCESSFULLY AND ALSO UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270394 ↗
• MalfunctionApr 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A 2.4MM/1.8MM DOUBLE DRILL SLEEVE DOES NOT FIT INTO THE DRILL GUIDE AND THAT REPAIR IS REQUIRED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR THE DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106594 ↗
• MalfunctionNov 18, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE AIMING GUIDE WAS BENT AND UNABLE TO PASS THE DRILL BIT DUE TO A CURVE IN THE GUIDE TUBE. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). . THIS REPORT IS FOR 1 2.4MM/1.8MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10862251 ↗
• MalfunctionFeb 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DOUBLE DRILL SLEEVE WAS BENT. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9688655 ↗
• MalfunctionJan 31, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE ISSUE WAS DISCOVERED DURING A ROUTINE EQUIPMENT CHECK AFTER DECONTAMINATION. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9654994 ↗