NA 03.111.701Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982072535), received between Mar 5, 2019 and Apr 22, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 18, 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 24957603 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 10/23/2024, THE GUIDE LOCK WOULD NOT ALLOW THE CORTICAL SCREWS TO LOCK.

  Patient problems: Insufficient Information

  MAUDE report 20592324 ↗
• MalfunctionJan 29, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 11, 2024, WHEN THE J&J¿S DISTRIBUTOR WAS CHECKING THE VATCP INSTRUMENTS BEFORE SURGERY, IT NOTICED THAT THE SCREW THAT CONNECTS THE GUIDING BLOCK TO THE PLATE WAS BENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDING BLOCK F/2-COLUMN DIST-RAD-PL2.4 7 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602436 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, THE TRAYS AND INSTRUMENTS WERE BROKEN. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/LEFT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662965 ↗
• MalfunctionJul 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL RADIUS SYSTEM IMPLANTATION, WHILE INSERTING AN UNKNOWN VOLAR VARIABLE ANGLE (VA) PLATE, THE SURGEON WAS USING A GUIDE BLOCK ON THE UNKNOWN PLATE. THE SURGEON PREFERRED INSERTING PROVISIONAL 2.4MM CORTEX SCREWS IN THE DISTAL PORTION OF THE UNKNOWN PLATE THROUGH THE GUIDE BLOCK. HOWEVER, TWO (2) OF THE CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK. ONE OF THEM DID. THE SURGEON UNDERSTOOD THAT THE UNKNOWN VARIABLE ANGLE (VA) LOCKING SCREWS ARE TO BE USED IN THE DISTAL PORTION, CORTEX SCREWS HAVE BEEN USED IN THE PAST TO COMPRESS THE UNKNOWN PLATE PROVISIONALLY BEFORE REPLACING WITH AN UNKNOWN VA VARIABLE ANGLE (VA) LOCKING SCREWS. THE SURGEON INSERTED AN UNKNOWN VARIABLE ANGLE (VA) LOCKING SCREWS INSTEAD OF A CORTEX SCREWS. THE ISSUE WAS THAT THE 2.4MM CORTEX SCREWS HEADS ARE DIFFERENT DIAMETERS AND SOME WOULD NOT FIT THROUGH THE GUIDE BLOCK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), 2.4MM CORTEX SCREW SLF-TPNG WIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289884 ↗
• 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 8 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629138 ↗
• 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 7 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629119 ↗
• MalfunctionMar 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS UNABLE TO SCREW THE AIMING BLOCK FOR DISTAL RADIUS PLATE ONTO THE PLATE. THE ATTEMPT WAS MADE USING DIFFERENT PLATES. THE SURGEON SUGGESTED THAT THE SCREW MIGHT BE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: DISTAL RADIUS PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/LEFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8391814 ↗