NA 323.26Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10886982190796), received between Nov 6, 2017 and Jun 1, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Mechanical Problem

  IT WAS REPORTED THAT THE SPRING IN THE DRILL GUIDE NO LONGER OPERATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350859 ↗
• MalfunctionApr 21, 2026Device-Device Incompatibility

  PREOPERATIVELY, THE 2.7 DRILL GUIDE DOES NOT FIT THE 2.0 DRILL. THERE ARE NO ALLEGATIONS AGAINST THE 2.0 DRILL BIT. THE DRILL GUIDE WAS DISPOSED OF BY THE FACILITY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS A SURGICAL DELAY OF FIFTEEN MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944844 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRING SIDE OF DRILL GUIDE WAS STICKY AND DID NOT ACCEPT A 2.0 DRILL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389811 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TISSUE GUIDES AND A BROKEN MODULE WERE FOUND DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20682996 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TISSUE GUIDES AND A BROKEN MODULE FOUND DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665375 ↗
• MalfunctionOct 4, 2024Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT ON OCTOBER 02, 2024 THE DRILL GUIDE SPRING AND PIECE ARE STUCK INSIDE, ENDS OF DRILL GUIDE ARE BENT OUTWARDS AND CAN NOT SLIDE CAP THROUGH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20373082 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDES WERE BENT AND MISSING THEIR INNER SLEEVES. THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 6 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255567 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDES WERE BENT AND MISSING THEIR INNER SLEEVES. THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255566 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDES WERE BENT AND MISSING THEIR INNER SLEEVES. THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255565 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDES WERE BENT AND MISSING THEIR INNER SLEEVES. THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255561 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDES WERE BENT AND MISSING THEIR INNER SLEEVES. THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255559 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDES WERE BENT AND MISSING THEIR INNER SLEEVES. THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255556 ↗
• MalfunctionSep 20, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SOME ITEMS WERE REMOVED FROM A MODULAR MINI-FRAGMENT AND NEEDED TO BE REPLACED. 2.0 AND 2.4/2.7 BENDING IRONS ARE BLEEDING A RUST-LOOKING SUBSTANCE FROM THE LETTERING PRINTED. THE DRILL GUIDE CANNOT SEPARATE THE INSERTS TO DISASSEMBLE BECAUSE THE THREADED TIP WON¿T SLIDE OVER THE INSERT. THE DEPTH GAUGE TIP IS BENT. THE 2.7-MODULE SIDE IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENTS OCCURRED. THIS REPORT IS FOR ONE (1)2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785367 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151916 ↗
• 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) 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957067 ↗
• 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) 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957065 ↗
• 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) AND (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) 2.7MM UNIVERSAL DRILL GUIDE THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955831 ↗
• MalfunctionApr 5, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE ATTEMPTING TO PASS A 2.7 DRILL BIT THROUGH A GUIDE, THE GUIDE WAS FOUND TO BE DAMAGED. ANOTHER GUIDE WAS CHOSEN AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK DRILL BITS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A 2.7MM UNIVERSAL DRILL GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685307 ↗
• MalfunctionDec 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, WHEN INVENTORYING ONE OF THE DISTAL RADIUS SETS, IT WAS NOTICED THAT THE 2.7 DRILL GUIDE END OF A UNIVERSAL DRILL GUIDE WAS BENT AND WOULD NOT ALLOW THE DRILL BIT TO PASS THROUGH THE GUIDE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931130 ↗
• 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) 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546606 ↗
• MalfunctionJul 13, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE A LOAN ORTHOKIT WAS RECEIVED IN LOCAL DC WITH A NON-SPRING DRILL GUIDE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000749 ↗
• MalfunctionJun 17, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PART IS INCOMPLETE. THIS REPORT INVOLVES ONE (1) 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733574 ↗
• MalfunctionJun 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2022, THE 2.7MM DRILL BIT WOULD NOT EASILY PASS THROUGH THE 2.7MM DRILL GUIDE. ANOTHER GUIDE WAS SELECTED. DURING POST SURGICAL INSPECTION IT WAS IDENTIFIED THAT THE DRILL GUIDE WAS DAMAGED IN OR AROUND THE CANNULATED DONE PRIOR TO THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS GOOD. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652362 ↗
• MalfunctionMay 10, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE CLEANING AND TAKING APART ITEM THE STERILE PROCESSING TECH NOTICED SOME RUST LOOKING RESIDUE ON THE DRILL GUIDE, AND SPRING. SHE SAID SHE TRIED TO SCRUB IT WITH A WIRE BRUSH BUT WHEN SHE DID THE SPRING BEGAN TO DISINTEGRATE AND SHE WAS UNABLE TO REMOVE ALL THE RUST FROM THIS ITEM. THE PATIENT DID NOT EXPERIENCE ANY POST-OP DEVICE MALFUNCTION. NO REVISION SURGERY WAS REQUIRED. NO PATIENT OUTCOME STATUS WAS REPORTED. THIS COMPLAINT INVOLVES ONE DEVICE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345395 ↗
• MalfunctionMar 7, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AT FSL UPS HOUSTON, TX SITE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, 323.26, 2.7MM UNIVERSAL DRILL GUIDE, LOT 52P1979 WAS OBSERVED BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED. A REPLACEMENT DEVICE HAS BEEN ORDERED. NO REPLACEMENT PRODUCT IS REQUIRED, AND NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685746 ↗