NA 323.202Recalls & reported problems
Synthes GmbH · 2.4MM UNIVERSAL DRILL GUIDE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes universal drill guide is a surgical instrument used to guide drills. The 52 reports mostly describe parts breaking, bending or getting stuck and being hard to separate, with no deaths and 1 injury mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10886982190789), received between May 26, 2017 and Jun 18, 2025 — classified as 1 injury, 51 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break30
- Material Deformation9
- Device-Device Incompatibility8
- Material Twisted/Bent2
- Use of Device Problem2
- Appropriate Device Problem Term/Code Not Available1
- Component Missing1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient10
- No Patient Involvement9
- Insufficient Information2
- Injury1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON MAY 23, 2025, DURING PRE-DELIVERY INSPECTION IT WAS REVEALED THAT THE SCREW COULD NOT TURN AND THAT COULD NOT BE REMOVED FROM THE DRILL GUIDE AFTER STORE PICKUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283522 ↗MalfunctionAug 22, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20031870 ↗MalfunctionJul 22, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 2.4MM UNIVERSAL DRILL GUIDE IS DIFFICULT TO DISCONNECT. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 19800595 ↗MalfunctionDec 4, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND IN THE STERILE PROCESSING DEPARTMENT THAT THE SPRINGS WERE STRETCHED AND THE DRILL GUIDES WERE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 6 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255799 ↗MalfunctionDec 4, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND IN THE STERILE PROCESSING DEPARTMENT THAT THE SPRINGS WERE STRETCHED AND THE DRILL GUIDES WERE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 3 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255796 ↗MalfunctionDec 4, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND IN THE STERILE PROCESSING DEPARTMENT THAT THE SPRINGS WERE STRETCHED AND THE DRILL GUIDES WERE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 6 FOR (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255794 ↗MalfunctionDec 4, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND IN THE STERILE PROCESSING DEPARTMENT THAT THE SPRINGS WERE STRETCHED AND THE DRILL GUIDES WERE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 4 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255793 ↗MalfunctionDec 4, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND IN THE STERILE PROCESSING DEPARTMENT THAT THE SPRINGS WERE STRETCHED AND THE DRILL GUIDES WERE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 5 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255791 ↗MalfunctionDec 4, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND IN THE STERILE PROCESSING DEPARTMENT THAT THE SPRINGS WERE STRETCHED AND THE DRILL GUIDES WERE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255784 ↗MalfunctionNov 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE DRILL GUIDE IS TOO SMALL FOR THE 1.8 DRILL BIT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC WAS IDENTIFIED DURING THE LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. THIS REPORT IS FOR ONE (1) UNIV-DRILL-GUIDE 2.4. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093913 ↗MalfunctionMay 19, 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) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16961932 ↗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) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 7 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16956928 ↗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) 2.4MM UNIVERSAL DRILL GUIDE THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16955787 ↗MalfunctionApr 6, 2023Break; Use of Device Problem; Break; Use of Device Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SCREW TIP IS MISSING, DAMAGED, AND BROKEN SPRING. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) UNIV-DRILL-GUIDE 2.4 THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16691516 ↗MalfunctionMar 1, 2023Break; Break
DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS BROKEN. THIS REPORT IS FOR ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16463890 ↗MalfunctionFeb 9, 2023Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE BROKEN. THIS REPORT IS FOR ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 12 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16342349 ↗MalfunctionFeb 9, 2023Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 11 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16342343 ↗MalfunctionFeb 9, 2023Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 3 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16342265 ↗MalfunctionJan 13, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, AT THE TIME OF OPENING THE EQUIPMENT, IT WAS NOTICED THAT THE TWO UNIVERSAL GUIDES OF 2.4 AND 2.7 DO NOT THREAD WELL, NEITHER OF THEM HAD THE SPRING FOUND INSIDE. THIS REPORT IS FOR ONE (1) UNIV-DRILL-GUIDE 2.4. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16156639 ↗MalfunctionSep 21, 2022Break; Break
DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INTERACTION, DEFECTS WERE DISCOVERED DURING PRE-OP INSPECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15461888 ↗MalfunctionJul 22, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UNIVERSAL DRILL GUIDE WAS BROKEN AND WORN. THIS REPORT INVOLVES ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15084005 ↗MalfunctionApr 20, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE UNIVERSAL DRILL GUIDE IN QUESTION WAS DISASSEMBLED AT THE TIME OF DELIVERY. THE HOSPITAL HAD TROUBLE ASSEMBLING THE UNIVERSAL DRILL GUIDE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE UNIV-DRILL-GUIDE 2.4. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14159877 ↗MalfunctionApr 15, 2022Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FIELD STOCKING LOCATION (FSL) (B)(4), IT WAS OBSERVED THAT 323.202, 2.4MM UNIVERSAL DRILL GUIDE, LOT 3669305 WAS BROKEN. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14120553 ↗MalfunctionMar 11, 2022Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDE WAS DISCOVERED AS BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13738631 ↗MalfunctionFeb 28, 2022Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT FIELD STOCKING LOCATION (FSL), (B)(4) SITE., IT WAS OBSERVED THAT THE 2.4MM UNIVERSAL DRILL GUIDE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13620060 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page