NA 323.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886982190604), received between Mar 23, 2017 and Jan 16, 2026 — classified as 1 injury, 60 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (38 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A K-WIRE GOT STUCK IN DRILL GUIDE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095684 ↗
• MalfunctionAug 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON MENTIONED THAT DURING A FOOT SURGERY, THE THREADED LOCKING GUIDES WERE NOT ENGAGING IN THE PLATE AND THE HEAD OF THE SCREWDRIVER WAS NOT FULLY ENGAGING THE SCREW. USED THE OTHER SCREW DRIVER IN THE SET. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826880 ↗
• MalfunctionAug 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON MENTIONED THAT DURING A FOOT SURGERY, THE THREADED LOCKING GUIDES WERE NOT ENGAGING IN THE PLATE AND THE HEAD OF THE SCREWDRIVER WAS NOT FULLY ENGAGING THE SCREW. USED THE OTHER SCREWDRIVER IN THE SET. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826877 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT PAINT WAS CHIPPING OFF OF DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT CONSEQUENCES. NO OPERATION WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487158 ↗
• MalfunctionFeb 21, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADED GUIDES WON'T THREAD INTO PLATE BECAUSE OF STRIPPING. THERE WAS NO PATIENT INVOLVEMENT OR CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434352 ↗
• MalfunctionFeb 21, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADED GUIDES WON'T THREAD INTO PLATE BECAUSE OF STRIPPING. THERE WAS NO PATIENT INVOLVEMENT OR CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434349 ↗
• MalfunctionNov 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT DISTAL ULNA FRACTURE OSTEOSYNTHESIS FOR ULNAR FRACTURE ON DISTAL END OF ULNA WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE INSTALLATION OF LCP DRILL SLEEVE AGAINST DISTAL ULNA PLATE (DUP) WAS VERY DIFFICULT. THE SURGEON COMMENTED THAT ALTHOUGH THE PLATE IS THIN, IT IS DIFFICULT TO INSTALL DUE TO THE LACK OF THREADS IN THE SCREW HOLES. SURGEON WOULD ALSO LIKE TO VERIFY IF THE THREADED PORTION OF THE DRILL SLEEVE IN QUESTION WAS SHALLOW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20739953 ↗
• MalfunctionNov 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT DISTAL ULNA FRACTURE OSTEOSYNTHESIS FOR ULNAR FRACTURE ON DISTAL END OF ULNA WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE INSTALLATION OF LCP DRILL SLEEVE AGAINST DISTAL ULNA PLATE (DUP) WAS VERY DIFFICULT. THE SURGEON COMMENTED THAT ALTHOUGH THE PLATE IS THIN, IT IS DIFFICULT TO INSTALL DUE TO THE LACK OF THREADS IN THE SCREW HOLES. SURGEON WOULD ALSO LIKE TO VERIFY IF THE THREADED PORTION OF THE DRILL SLEEVE IN QUESTION WAS SHALLOW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738402 ↗
• MalfunctionOct 1, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DRILL BROKE OFF INSIDE OF GUIDE AND WAS STUCK. THE CASE WENT UNCOVERED AND WAS DISCOVERED IN POST OP INSPECTION. IT IS ALSO NOT KNOWN IF FRAGMENTS WERE GENERATED.

  Patient problems: Insufficient Information

  MAUDE report 20345674 ↗
• MalfunctionJul 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A SURGERY WITH THE DISTAL ULNA PLATE. THE DRILL SLEEVES IN QUESTION WERE DIFFICULT TO CONNECT TO THE PROXIMAL 4 HOLES OF THE PLATE. THE SURGERY ENDED WITHOUT ANY TROUBLE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE (1) 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 2 OF 3 FOR (B)(4). THE SAME EVENT OCCURRED IN 3 CASES ON THE SAME DAY AT THIS HOSPITAL. THE TWO ADDITIONAL CASES ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19825474 ↗
• MalfunctionJul 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A SURGERY WITH THE DISTAL ULNA PLATE. THE DRILL SLEEVES IN QUESTION WERE DIFFICULT TO CONNECT TO THE PROXIMAL 4 HOLES OF THE PLATE. THE SURGERY ENDED WITHOUT ANY TROUBLE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE (1) 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 3 FOR (B)(4). THE SAME EVENT OCCURRED IN 3 CASES ON THE SAME DAY AT THIS HOSPITAL. THE TWO ADDITIONAL CASES ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19825445 ↗
• MalfunctionJul 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DISTAL ULNA PLATE. THE DRILL SLEEVES IN QUESTION WERE DIFFICULT TO CONNECT TO THE PROXIMAL FOUR HOLES OF THE PLATE. THE SURGERY ENDED WITHOUT ANY TROUBLE. THIS REPORT INVOLVES ONE 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819099 ↗
• MalfunctionJul 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DISTAL ULNA PLATE. THE DRILL SLEEVES IN QUESTION WERE DIFFICULT TO CONNECT TO THE PROXIMAL FOUR HOLES OF THE PLATE. THE SURGERY ENDED WITHOUT ANY TROUBLE. THIS REPORT INVOLVES ONE 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819092 ↗
• MalfunctionJul 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DISTAL ULNA PLATE TREATING THE DISTAL END OF THE ULNA. THE DRILL SLEEVES IN QUESTION WERE DIFFICULT TO CONNECT TO THE PROXIMAL 4 HOLES OF THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19816868 ↗
• MalfunctionJul 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DISTAL ULNA PLATE TREATING THE DISTAL END OF THE ULNA. THE DRILL SLEEVES IN QUESTION WERE DIFFICULT TO CONNECT TO THE PROXIMAL 4 HOLES OF THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19816862 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT, AND THE PATIENT STATUS/OUTCOME WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807434 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 20, 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DISTAL ULNA PLATE AND THE DRILL GUIDE. THE SURGEON COMMENTED THAT IT WAS VERY DIFFICULT TO INSTALL THE DRILL SLEEVE TO THE PROXIMAL 4 HOLES OF THE PLATE SHAFT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18317391 ↗
• MalfunctionNov 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF FOR THE DISTAL ULNA FRACTURE. THE DRILL SLEEVES WERE DIFFICULT TO INSTALL ON THE PLATE. ONE OF THE DRILL SLEEVES COULD NOT BE INSTALLED ON THE PLATE AT ALL. THE OTHER ONE WAS EASIER TO INSTALL ON THE PLATE THAN THE FIRST ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LCP DRILL SLEEVE 2 W/SCAL F/DRILL BITS Ø THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18241831 ↗
• MalfunctionNov 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT THE ORIF FOR THE DISTAL ULNA FRACTURE. THE DRILL SLEEVES WERE DIFFICULT TO INSTALL ON THE PLATE. ONE OF THE DRILL SLEEVES COULD NOT BE INSTALLED ON THE PLATE AT ALL. THE OTHER ONE WAS EASIER TO INSTALL ON THE PLATE THAN THE FIRST ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LCP DRILL SLEEVE 2 W/SCAL F/DRILL BITS Ø THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 18241628 ↗
• InjuryMar 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE DRILL BIT AND THE DRILL SLEEVE FOR THE DISTAL ULNA. THE DRILL SLEEVE WAS ATTACHED TO THE PLATE. DURING DRILLING, THE DRILL BIT GOT STUCK IN THE SIDE WINDOW OF THE DRILL SLEEVE. THE TIP OF THE DRILL BIT HAS ALREADY ACHIEVED TO THE BONE, SO THAT THE PART OF THE DRILL BIT WAS CUT OFF. THERE WERE NO FRAGMENTS IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496820 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON FEBRUARY 08, 2023, DURING INTRA-OP DEPTH GAUGE DIDN'T SLIDE SMOOTHLY AND THET6 STAR-DRIVER WAS STRIPPED, THE 2.0 LOCKING TOWERS WOULDN'T LOCK INTO PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 THREADED DRILL GUIDE DEPTH GAUGE THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457315 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP DEPTH GAUGE DIDN'T SLIDE SMOOTHLY AND THET6 STAR-DRIVER WAS STRIPPED, THE 2.0 LOCKING TOWERS WOULDN'T LOCK INTO PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 THREADED DRILL GUIDE DEPTH GAUGE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456630 ↗
• MalfunctionDec 6, 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 PATIENT UNDERWENT SURGERY WITH THE PRODUCTS IN QUESTION. DURING THE SURGERY, THE SURGEON POINTED OUT THAT THE 2.0 LCP 1.5MM DRILL WAS DIFFICULT TO ATTACH TO THE LOCKING HOLE OF THE PLATE AND WOULD COME OFF IMMEDIATELY. OF THE SEVEN HOLES, THE DISTAL THREE HOLES COULD BE ATTACHED, BUT THE PROXIMAL FOUR HOLES WERE DIFFICULT TO ATTACH. ANOTHER DOCTOR WHO WAS ASSISTING POINTED OUT THAT THE SAME PHENOMENON HAD BEEN OCCURRING FOR SOME TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925475 ↗
• MalfunctionMay 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN JAPAN THAT ON (B)(6) 2022, A PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY USING THE LCP PLATE FOR FRACTURE OF DISTAL END OF RADIO-ULNA WITH THE DRILL SLEEVE AND THE SCREWDRIVER SHAFT IN QUESTION. ACCORDING TO THE REPORT, THE SURGEON HAD DIFFICULTY IN WEARING THE DRILL SLEEVE WHEN USING THE PLATE, AND IT TOOK TIME IN ALL HOLES. IT WAS FURTHER REPORTED THAT IT WAS DIFFICULT TO INSERT THE SCREW BECAUSE THE SCREW COULD NOT BE ATTACHED VERTICALLY TO THE SCREWDRIVER SHAFT. IT WAS REPORTED THAT BY CHANGING THE SCREWDRIVER SHAFT TO THE SHORT ONE, IT WAS SUCCESSFULLY INSERTED WITHOUT ANY PROBLEM. IT WAS REPORTED THAT DUE TO THESE EVENTS, THE OPERATION SCHEDULED FOR 2 HOURS WAS EXTENDED TO 3 HOURS. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT ANESTHESIOLOGISTS WARNED THE SURGEONS THAT A 3-HOUR OPERATION WAS A HIGH-RISK PROCEDURE FOR PATIENTS IN THEIR 90S. THE SURGEON UNDERSTOOD THAT THE PRODUCT WAS DIFFICULT TO OPERATE DUE TO THE INFLUENCE OF BLOOD ADHESION AND THE THINNESS OF THE PLATE. NO FURTHER I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501214 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE THREAD IN GUIDE BROKEN IN SPD. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759183 ↗