NA 323.201Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982190772), received between Aug 28, 2018 and Jan 30, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE INSTRUMENTS AND IMPLANTS WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273066 ↗
• 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 20881047 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED A DRILL GUIDE WAS MISSING A SPRING AND SHAFT. THE DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE INSPECTION OCCURRED APRIL 8, 2024, HOWEVER IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. THIS REPORT IS FOR ONE 2.0MM UNIVERSAL DRILL GUIDE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222338 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE FOUND BENT AND WITHOUT SPRINGS IN THE STERILE PROCESSING DEPARTMENT. THIS REPORT INVOLVES ONE 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256051 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE FOUND BENT AND WITHOUT SPRINGS IN THE STERILE PROCESSING DEPARTMENT. THIS REPORT INVOLVES ONE 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256050 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE FOUND BENT AND WITHOUT SPRINGS IN THE STERILE PROCESSING DEPARTMENT. THIS REPORT INVOLVES ONE 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256043 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE FOUND BENT AND WITHOUT SPRINGS IN THE STERILE PROCESSING DEPARTMENT. THIS REPORT INVOLVES ONE 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256042 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE FOUND BENT AND WITHOUT SPRINGS IN THE STERILE PROCESSING DEPARTMENT. THIS REPORT INVOLVES ONE 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256040 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE FOUND BENT AND WITHOUT SPRINGS IN THE STERILE PROCESSING DEPARTMENT. THIS REPORT INVOLVES ONE 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256039 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED, THAT SCREWDRIVERS ARE STRIPPED AND DRILL GUIDES ARE BROKEN. IT WAS UNKNOWN, IF THERE WERE PATIENT INVOLVEMENT, OR PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TEN (10) DEVICES. (B)(4) ARE RELATED TO CAPTURE ADDITIONAL IPS. (B)(4) INCLUDES: SDDRIVE SCREWDRIVER SHAFT T8 105MM (314.467) X1, SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 (313.843) X1, 2.7MM/2.0MM DOUBLE DRILL SLEEVE (312.24) X2, 2.4MM/1.8MM DOUBLE DRILL SLEEVE (312.18) X2, 2.0MM/1.5MM DOUBLE DRILL SLEEVE (312.22) X2, 2.7MM UNIVERSAL DRILL GUIDE (23.26) X3, 2.4MM UNIVERSAL DRILL GUIDE (323.202) X3, 2.0MM UNIVERSAL DRILL GUIDE (323.201) X3. (B)(4) INCLUDES: SDDRIVE SCREWDRIVER SHAFT T8 105MM (314.467) X2, SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 (313.843) X2. THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957054 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED, THAT SCREWDRIVERS ARE STRIPPED AND DRILL GUIDES ARE BROKEN. IT WAS UNKNOWN, IF THERE WERE PATIENT INVOLVEMENT, OR PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TEN (10) DEVICES. (B)(4) ARE RELATED TO CAPTURE ADDITIONAL IPS. (B)(4) INCLUDES: SDDRIVE SCREWDRIVER SHAFT T8 105MM (314.467) X1, SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 (313.843) X1, 2.7MM/2.0MM DOUBLE DRILL SLEEVE (312.24) X2, 2.4MM/1.8MM DOUBLE DRILL SLEEVE (312.18) X2, 2.0MM/1.5MM DOUBLE DRILL SLEEVE (312.22) X2, 2.7MM UNIVERSAL DRILL GUIDE (23.26) X3, 2.4MM UNIVERSAL DRILL GUIDE (323.202) X3, 2.0MM UNIVERSAL DRILL GUIDE (323.201) X3. (B)(4) INCLUDES: SDDRIVE SCREWDRIVER SHAFT T8 105MM (314.467) X2, SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 (313.843) X2. THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956925 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED THAT SCREWDRIVERS ARE STRIPPED AND DRILL GUIDES ARE BROKEN. IT WAS UNKNOWN IF THERE WERE PATIENT INVOLVEMENT, OR PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TEN (10) DEVICES. (B)(4) ARE RELATED TO CAPTURE ADDITIONAL IPS. (B)(4) INCLUDES, SDDRIVE SCREWDRIVER SHAFT T8 105MM (314.467) X1, SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 (313.843) X1, 2.7MM/2.0MM DOUBLE DRILL SLEEVE (312.24) X2, 2.4MM/1.8MM DOUBLE DRILL SLEEVE (312.18) X2, 2.0MM/1.5MM DOUBLE DRILL SLEEVE (312.22) X2, 2.7MM UNIVERSAL DRILL GUIDE (23.26) X3, 2.4MM UNIVERSAL DRILL GUIDE (323.202) X3, 2.0MM UNIVERSAL DRILL GUIDE (323.201) X3, (B)(4) INCLUDES, SDDRIVE SCREWDRIVER SHAFT T8 105MM (314.467) X2, SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 (313.843) X2. THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955778 ↗
• MalfunctionFeb 13, 2023Misassembled; Device-Device Incompatibility; Misassembled; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING REPROCESSING OF THE MODULAR HAND SET, THE SPRING WAS MISPLACED IN ERROR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363770 ↗
• MalfunctionOct 5, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT UPON INSPECTION, THE INSTRUMENT ROOM TECHNICIAN NOTED DAMAGED TIPS ON THE ENDS OF BOTH UNIVERSAL DRILL GUIDES 323.201 AND 323.26. THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546610 ↗
• MalfunctionAug 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE ATTEMPTING TO DRILL WITH A 2.0 DRILL BIT, THE DRILL BIT WOULD NOT PASS THROUGH THE 2.0/2,7 UNIVERSAL GRILL GUIDE. IT¿S POSSIBLE THAT THE DRILL GUIDE WAS DAMAGED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT GUIDE, SURGICAL, INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165182 ↗
• MalfunctionDec 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.0MM UNIVERSAL DRILL GUIDE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028843 ↗
• MalfunctionNov 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE UNIVERSAL DRILL GUIDE WAS BENT AND WOULD NOT ALLOW A DRILL BIT TO SLIDE THROUGH IT. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. CONCOMITANT DEVICE: UNK - DRILL BITS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896096 ↗
• MalfunctionJan 10, 2020Component Missing; Material Deformation; Component Missing; Material Deformation

  IT WAS REPORTED THAT DURING AN INCOMING ROUTINE INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, A UNIVERSAL DRILL GUIDE WAS NOTED TO HAVE A MISSING PIECE. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION ON (B)(6) 2020 OF THE RETURNED DEVICE, IT WAS IDENTIFIED THAT THE SPRING AND SLEEVE WERE MISSING AND THE FIXED SLEEVE IS DEFORMED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9577171 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE PROCEDURE, THE WELDING OF THE UNIVERSAL DRILL GUIDE WAS BROKE IN HALF. ANOTHER DRILL GUIDE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL DRILL GUIDE. THIS REPORT IS FOR 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705334 ↗
• MalfunctionSep 11, 2018Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE UNIVERSAL DRILL GUIDE WAS BENT RENDERING THE PRODUCT TO BE NO LONGER FUNCTIONAL. THE ISSUE WAS NOTICED BY THE MEDICAL DEVICE REPORTING STAFF ON AN UNKNOWN DATE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7863995 ↗
• MalfunctionAug 28, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 2.0 MM UNIVERSAL DRILL GUIDE WAS NOTED TO BE MISSING A SPRING. IT IS UNKNOWN IF THERE WAS A PROCEDURE INVOLVED. THIS IS A VETERINARY COMPLAINT; THERE IS NO HUMAN PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7824693 ↗