NA 04.130.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982112750), received between Feb 12, 2018 and Dec 12, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR METACARPAL ON MIDDLE FINGER WITH VA-HAND AND THE PRODUCTS IN QUESTION. IN THE SURGERY, THE HEADS OF THE SCREWS IN QUESTION WERE DAMAGED WHEN THE LAST FASTENING WAS ATTEMPTED. THE DRILL TIP WAS THEN DAMAGED WHEN DRILLING THE NEXT HOLE. THE DRILL TIP WAS ALSO BROKEN IN THE NEXT HOLE. THE SCREWS WITH A BROKEN HEADS AND TWO BROKEN DRILL TIPS HAVE BEEN IMPLANTED IN THE BODY AT THE SURGEON'S DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20913917 ↗
• MalfunctionSep 26, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR THIRD AND FOURTH METACARPAL FRACTURE WITH SCREWDRIVER SHAFT, DRILL BIT, VA LOCKING STRAIGHT PLATE AND LOCKING SCREWS. WHILE THE SURGEON WAS DRILLING TO FIX THE VA LOCKING STRAIGHT PLATE, THE DRILL BIT BROKE. FORTUNATELY, THE DRILL BIT COULD BE REMOVED FROM THE BODY, AND THE SURGERY PROCEEDED. NEXT, THE SCREWDRIVER SHAFT BROKE WHEN INSERTING THE LOCKING SCREW. BUT THIS ONE WAS ALSO REMOVED FROM THE BODY. THE SURGEON PROCEEDED WITH THE SURGERY USING A SCREWDRIVER OF THE SAME STANDARD. AFTER THAT, WHEN INSERTING ANOTHER LOCKING SCREW, TWO SCREW HEADS BROKE. THE SURGEON REMOVED ONE LOCKING SCREW, BUT THE OTHER LOCKING SCREW WAS INSERTED IN A GOOD POSITION FOR FIXATION, SO THE SURGEON LEFT IT IN PLACE AND REMOVED THE IMPLANT. THE SURGEON THEN CHANGED TO 2.0MM PLATE AND SCREW AND FIXED IT, COMPLETING THE SURGERY. ALL THAT REMAINS IN THE PATIENT¿S BODY IS A SINGLE SCREW WITH A BROKEN SCREW HEAD. THE SURGEON THOUGHT THE CAUSE OF THE FRACTURE WAS THAT THE PATIENT WAS 19 YEARS OLD AND HAD GOOD BONE QUALITY. THE SURGERY WAS COMPLETED SUCCESSFULLY MORE TH

  Patient problems: Insufficient Information

  MAUDE report 17820410 ↗
• MalfunctionSep 26, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR THIRD AND FOURTH METACARPAL FRACTURE WITH SCREWDRIVER SHAFT, DRILL BIT, VA LOCKING STRAIGHT PLATE AND LOCKING SCREWS. WHILE THE SURGEON WAS DRILLING TO FIX THE VA LOCKING STRAIGHT PLATE, THE DRILL BIT BROKE. FORTUNATELY, THE DRILL BIT COULD BE REMOVED FROM THE BODY, AND THE SURGERY PROCEEDED. NEXT, THE SCREWDRIVER SHAFT BROKE WHEN INSERTING THE LOCKING SCREW. BUT THIS ONE WAS ALSO REMOVED FROM THE BODY. THE SURGEON PROCEEDED WITH THE SURGERY USING A SCREWDRIVER OF THE SAME STANDARD. AFTER THAT, WHEN INSERTING ANOTHER LOCKING SCREW, TWO SCREW HEADS BROKE. THE SURGEON REMOVED ONE LOCKING SCREW, BUT THE OTHER LOCKING SCREW WAS INSERTED IN A GOOD POSITION FOR FIXATION, SO THE SURGEON LEFT IT IN PLACE AND REMOVED THE IMPLANT. THE SURGEON THEN CHANGED TO 2.0MM PLATE AND SCREW AND FIXED IT, COMPLETING THE SURGERY. ALL THAT REMAINS IN THE PATIENT¿S BODY IS A SINGLE SCREW WITH A BROKEN SCREW HEAD. THE SURGEON THOUGHT THE CAUSE OF THE FRACTURE WAS THAT THE PATIENT WAS 19 YEARS OLD AND HAD GOOD BONE QUALITY. THE SURGERY WAS COMPLETED SUCCESSFULLY MORE T

  Patient problems: Insufficient Information

  MAUDE report 17819753 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN SURGICAL PROCEDURE, THE TWO (2) SCREW HEADS BROKE WHILE INSERTING INTO THE BONE AFTER DRILLING. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760196 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN SURGICAL PROCEDURE, THE TWO (2) SCREW HEADS BROKE WHILE INSERTING INTO THE BONE AFTER DRILLING. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760169 ↗
• InjuryFeb 12, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS USED IN THE SURGERY FOR THE FRACTURE OF THE LEFT SECOND METACARPAL BONE ON (B)(6) 2017. THE VARIABLE ANGLE (VA) LOCKING Y-SHAPE PLATE WAS USED FOR THE FIXATION. AFTER THE FIXATION WITH THE PROXIMAL THREE SCREWS AND DISTAL TWO SCREWS BY USING THE VA SLEEVE, RE-REDUCTION WAS NEEDED SO THE DISTAL SCREWS WERE REMOVED ONCE. WHEN THE VA DRILLING WAS DONE AGAIN AFTER RE-REDUCTION, THE LOCKING SCREW WAS INSERTED AND IT WAS FOUND THAT THE PLATE WAS NOT LOCKED BY THE SCREW. WHEN THE FIX-MODE DRILLING WAS DONE TO ANOTHER HOLE, AND THE LOCKING SCREW WAS INSERTED, IT WAS ALSO FOUND THAT THE PLATE WAS NOT LOCKED BY THE SCREW. BECAUSE THE FIXATION WAS NOT POSSIBLE AT THIS MOMENT, THE SURGEON DECIDED TO REPLACE THE PLATE IN QUESTION. WHEN THE SURGEON TRIED TO REMOVE THE Y-SHAPE PLATE IN QUESTION, THE PLATE COULD NOT BE REMOVED SINCE THE PROXIMAL TWO SCREWS WERE SPINNING AROUND. EVENTUALLY, THE PLATE IN QUESTION WAS CUT AND REMOVED FROM THE PATIENT. THE SURGEON REPLACED AND FIXED WITH THE T-SHAPE PLATE (1.5 MM). THE SURGEON COMMENTED THAT SINCE THE VA SLEEVE WAS DRILLED BEYOND THE RANGE OF T

  Patient problems: No Code Available

  MAUDE report 7264340 ↗