NA 03.111.601Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982072474), received between May 21, 2019 and Apr 22, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Break

  DROP IN GUIDE HAS BROKEN AND IS UNUSABLE. GUIDE BLOCKS HAVE ALSO BROKEN WHERE THREADS ARE FOR THE SCREW. ISSUE OCCURRED DURING CONTINUED USE INTRAOPERATIVELY OVER TIME; WAS NOTICED POST-OP DURING REASSEMBLY. DEVICES HAVE BEEN DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957585 ↗
• MalfunctionJul 3, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP). ALL ITEMS WERE NOTICED PRE-OP BEFORE A PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394520 ↗
• MalfunctionMay 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW BENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004924 ↗
• MalfunctionNov 13, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. IN THE SURGERY, WHEN A NURSE ATTEMPTED TO CONNECT THE GUIDING BLOCK TO THE PLATE, THE PLATE AND THE GUIDING BLOCK DID NOT ENGAGE NO MATTER HOW MANY TIMES THE NURSE TRIED. WHEN THE SURGEON TRIED, THE BLOCK CONNECTION BROKE OFF WITH THE THREADING ENGAGED IN THE PLATE. SINCE THE THREADED PORTION OF THE GUIDING BLOCK REMAINED ON THE PLATE IN QUESTION, A PLATE ONE SIZE SMALLER (LEFT SMALL 3-HOLE LEFT EX SMALL 3-HOLE) WAS USED FOR FIXATION WITHOUT ANY PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY, PATIENT STATUS/ OUTCOME REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677219 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE GUIDE LOCK WOULD NOT ALLOW THE CORTICAL SCREWS TO LOCK.

  Patient problems: Insufficient Information

  MAUDE report 20592321 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON SELECTED A 2.4 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP)) TWO-COLUMN VOLAR DISTAL RADIUS PLATE FOR A PATIENT. THE SCREW/PIN ON THE LEFT GUIDE BLOCK SNAPPED OFF WHILE SURGEON WAS ATTEMPTING TO THREAD THE GUIDE BLOCK ONTO THE PLATE. NO ADVERSE AFFECT TO PATIENT WAS CAUSED BY THIS EVENT, HOWEVER THE GUIDE BLOCK IS NOW UN-USABLE WITHOUT THE CONNECTING SCREW/PIN. SURGEON REMOVED DAMAGED EQUIPMENT FROM STERILE FIELD AND PROCEEDED WITHOUT USING GUIDE BLOCKS. THERE WAS NO SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181020 ↗
• MalfunctionApr 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY, WHEN THE GUIDING BLOCK WAS CONNECTED TO A QUICK DRILL SLEEVE, IT COULD NOT BE CONNECTED ALL THE WAY TO THE BACK. THE SURGERY WAS SUCCESSFULLY COMPLETED USING THE INSTRUMENT CONCERNED. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. AFTER THE SURGERY, THE SALES REP CHECKED IF THE GUIDING BLOCK WAS ABLE TO BE CONNECTED TO THE QUICK DRILL SLEEVE. THE GUIDING BLOCK WAS ABLE TO BE CONNECTED TO THE QUICK DRILL SLEEVE BUT SEEMED HARDER TO CONNECT THAN OTHER SIZES OF GUIDE BLOCKS. THIS REPORT INVOLVES ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154206 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WERE UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1)GUIDE BLOCK FOR 2 COLM PL 6 HOLE HD/LFT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839133 ↗
• MalfunctionNov 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR DISTAL RADIUS FRACTURE WITH THE PRODUCT IN QUESTION. DURING THE SURGERY, WHEN THE SCREW WAS TURNED TO ATTACH THE SAID GUIDING BLOCK TO THE PLATE, THERE WERE NO RESISTANCE, AND THE SCREW BROKE OFF WHILE STILL ENGAGED IN THE PLATE. THE SURGEON DETERMINED THAT IT COULD NOT BE TAKEN OUT DURING THE SURGERY, SO HE CHANGED THE PLATE FROM TWO TO THREE HOLES AND PROCEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE SURGEON EXPLAINED THAT HE HAD JUST TURNED IT WITH HIS FINGER, WITHOUT ANY SCREWDRIVERS, AND ASKED FOR THE BLOCK TO BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDINGBLOCK F/2-COLUMN DIST-RAD-PL2.4 6. THIS IS REPORT 1 OF 2 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788418 ↗
• MalfunctionNov 9, 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 OPEN REDUCTION INTERNAL FIXATION FOR A DISTAL RADIUS FRACTURE WITH THE PRODUCT IN QUESTION. DURING THE SURGERY, WHEN THE GUIDE BLOCK WAS ATTACHED TO THE PLATE AND RETIGHTENED WITH A SCREWDRIVER, THE HANDLE WAS DAMAGED AND THE TIP OF THE HANDLE WAS BURIED IN THE PLATE. THE SURGEON WAS ABLE TO REMOVE THE TIP WITH RADIO PLIERS BUT WAS UNABLE TO USE A GUIDING BLOCK, SO HE USED A THREADED DRILL GUIDE. THE SURGERY WAS COMPLETE SUCCESSFULLY WITH A 30 MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761793 ↗
• MalfunctionJan 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF DISTAL RADIUS. IN THE SURGERY, THE SCREW OF THE GUIDING BLOCK BROKE. THE BROKEN PART OF THE SCREW STUCK TO THE HOLE OF THE PLATE AND COULD NOT BE REMOVED. THE SURGEON GAVE UP USING THE PLATE AND USED ANOTHER NEW PLATE. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO(2) DEVICES. THIS REPORT IS FOR (1) UNK - GUIDES/ SLEEVES/AIMING. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155483 ↗
• MalfunctionNov 6, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS (B)(6) SITE, IT WAS OBSERVED THAT THE GUIDE BLOCK FOR 2 COLUMN PLATE WAS BENT. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10804485 ↗
• MalfunctionOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, WHEN THE SURGEON CONNECTED THE DRILL SLEEVE TO THE GUIDING BLOCK, THEY COULDN¿T CONNECT PROPERLY. IT WAS POSSIBLE THAT THERE WAS CLOTTED BLOOD IN THE GUIDING BLOCK HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A GUIDE BLOCK. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727798 ↗
• MalfunctionMay 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, SIX (6) GUIDING BLOCKS FOR A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO COLUMN DISTAL RADIUS PLATE DID NOT FIT CORRECTLY ON TWO (2) PLATES. A SCREW TO FIX THE GUIDING BLOCKS ON THE PLATE WAS TOO LONG RESULTING IN THE PLATE NOT BEING PLACED PROPERLY ON THE BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A PLATE WITH NO GUIDING BLOCK. THERE WAS NO PATIENT HARM OR INTERVENTION REQUIRED THIS REPORT IS FOR A VA-LCP PLATE. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629017 ↗