NA 03.111.500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982072429), received between Jul 19, 2018 and Apr 22, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 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 24957582 ↗
• MalfunctionJul 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A DISTAL RADIUS FRACTURE WITH THE GUIDING BLOCK/ IT WAS DIFFICULT TO ATTACH THE DRILL SLEEVE TO THE GUIDING BLOCK DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/RT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260134 ↗
• MalfunctionOct 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SURGEON ATTEMPTED TO PUT A GUIDE BLOCK AND SCREW THROUGH THE DRILL HOLES. THE ISSUE OCCURRED WHILE THE ATTACHMENT SCREW GOING TO THE PATIENT'S BODY VIA THE GUIDE BLOCK. WE ARE DOING A DISTAL FIBULA PLATE FOR A PATIENT AND DRILLED FOR A LOCKING SCREW THEN USE THE POWER SHAFT. THE LOCKING SCREW WOULD NOT STICK TO THE TIP OF THE SCREWDRIVER SHAFT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE HAND SCREWDRIVER AND A SURGICAL DELAY OF THIRTY(30) SECONDS. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: DISTAL RADIUS: (PART#UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/RT. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665148 ↗
• MalfunctionJun 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. THE SURGEON WAS PUTTING ON THE NARROW GUIDE BLOCK FOR THE VARIABLE ANGLE DISTAL RADIUS PLATE, THE THREADS BROKE OFF, AND THE POST BROKE IN HALF. THE POST WAS RETRIEVED WITH A PICK-UP, THEY THREADED ANOTHER PAIR FROM THE CONTRALATERAL GUIDE BLOCK INTO IT. THE CASE WENT ON AS NORMAL WITH NO ISSUE. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/RT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068222 ↗
• MalfunctionNov 18, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR RIGHT DISTAL RADIUS WITH A VA TWO-COLUMN PLATE AND THE GUIDING BLOCK IN QUESTION. DURING THE SURGERY, THE SURGEON TRIED TO CONNECT THE GUIDING BLOCK TO THE PLATE. WHEN TURNED THE SCREW OF THE GUIDING BLOCK WITH A SCREWDRIVER, THE SCREW PART OF THE GUIDING BLOCK BROKE. THE SURGEON DRILLED THE DISTAL SCREW HOLE WITH A DRILL SLEEVE BECAUSE HE COULD NOT USE THE GUIDING BLOCK, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN SCREWDRIVERS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336535 ↗
• MalfunctionOct 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SOME OF THE 2.4 MM CORTEX SCREWS WERE NOT FITTING THROUGH THE PLATE GUIDES FOR THE TWO COLUMN VARIABLE ANGLE DISTAL RADIUS PLATES. THE SET WAS OPENED AND TESTED THE THREE (3) 2.4 MM CORTEX SCREWS 20 MM, TWO (2) 2.4 MM CORTEX 22 MM, AND ONE (1) 2.4 MM CORTEX 24 MM. THE 2.4 MM CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK FOR TWO-COLUMN PLATE 6 HOLE HEAD, GUIDE BLOCK FOR TWO-COLUMN PLATE 7 HOLE HEAD, NOR THE GUIDE BLOCK FOR TWO-COLUMN PLATE NARROW 6 HOLE. THE REST OF THE 2.4 MM CORTEX SCREWS DID. THE ISSUE WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS IS 3 OF 9 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244348 ↗
• InjuryNov 13, 2018Use of Device Problem; Use of Device Problem

  SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE DISTAL RADIUS END FRACTURE IN THE RIGHT ARM ON (B)(6) 2018, DURING THE SURGERY, A GUIDING BLOCK FOR TWO-COLUMN DISTAL RADIUS PLATE WAS MOUNTED TO THE VARIABLE ANGLE LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE(STERILE) BY TURNING THE ATTACHMENT SCREW WITH AN UNKNOWN DRIVER. THE SCREW CONTINUED TO TURN EVEN THE BLOCK HAS ALREADY BEEN FIXED TO THE PLATE AND THE BLOCK IS UNABLE TO BE DETACHED FROM THE PLATE. THE SURGEON USED ANOTHER AN UNKNOWN NEW PLATE AND FIXED IT TO THE BONE WITHOUT USING A GUIDING BLOCK. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE AND PATIENT OUTCOME IS STABLE. THIS COMPLAINT IS FOR ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/RT CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVERS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8066916 ↗
• MalfunctionJul 19, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN ON (B)(6) 2018, OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH VA-LCP (VARIABLE ANGLE-LOCKING COMPRESSION PLATE) SYSTEM WAS APPLIED TO DISTAL RADIUS FRACTURES. WHEN THE SURGEON TRIED TO FIX THE GUIDE BLOCK TO A PLATE, THE SCREW OF THE GUIDE BLOCK BROKE OFF. THIS BREAKAGE OCCURRED OUTSIDE OF PATIENT¿S BODY, AND FRAGMENT DID NOT ENTER THE PATIENT. THE FRAGMENT WAS REMOVED FROM THE PLATE, AND THE GUIDE BLOCK WAS SECURED TO THE PLATE WITH A REPLACEMENT SCREW. THE SURGERY WAS COMPLETED WITHIN A 30-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/RT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7703058 ↗