NA 390.051Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982198082), received between Sep 28, 2020 and Aug 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K031973, K033158, K090658, K963618); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2025 THE DEVICE 4.0/3.0 SELF-DRILL SCHANZ SCR 20 THRD/80, WOULD NOT ENGAGE IN ADAPTER, THE 4.0 ADJUSTABLE CLAMP DSTL RAD FIXATOR, CLAMP BROKE AND THE SDDRIVE SCREWDRIVER SHAFT T8 105MM TIP SNAPPED OFF. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22908647 ↗
• MalfunctionJun 12, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE SCREW WON'T TURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192658 ↗
• MalfunctionDec 13, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WRENCH IS BROKEN AND CANNOT BE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 20924331 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE SCREW CAME OFF OF THE CLAMP. THIS REPORT IS FOR A 4.0MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR.

  Patient problems: Insufficient Information

  MAUDE report 20237370 ↗
• MalfunctionOct 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO MOVE. NO FURTHER INFORMATION IS AVAILABLE.THIS REPORT IS FOR ONE (1) 4.0MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR.THIS IS REPORT 1 OF 1 FOR COMPLAINT PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016320 ↗
• MalfunctionSep 28, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE EXTERNAL SKELETAL FIXATION FOR DISTAL RADIUS FRACTURES BY USING THE CLAMP IN QUESTION. DURING THE SURGERY, WHEN THE SURGEON WAS SETTING UP THE CLAMP, HE COULD NOT TIGHTEN THE SCREW OF THE CONNECTION PART OF THE CLAMP. BEFORE SETTING UP THE CLAMP, HE CONFIRMED THAT THE SCREW OF THE CLAMP COULD BE TIGHTENED, AND THE SCREW PART WORKED. HOWEVER, AFTER SETTING UP THE CLAMP AFTER SELDRILL WAS INSERTED, HE REALIZED THAT THE SCREW OF THE CLAMP PLACED AT PROXIMAL END COULD NOT BE TIGHTENED. HE TRIED TO TIGHTEN THE SCREW OF THE CLAMP BY USING A DRIVER SEVERAL TIMES AND HE COULD NOT TIGHTEN IT WHILE THE SCREW WAS ROTATING IDLE. ANOTHER CLAMP WAS NOT AVAILABLE, SO THE SURGEON USED A MEDIUM EXTERNAL FIXATOR TO PLACE THE CLAMP FOR FIXATION WHILE HE WAS ENGAGING THE ALREADY INSERTED SELDRILL WITH THE CLAMP. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SELDRILL SCHANZ SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN DRIVER (PART # UNKNOWN, LOT # UNKNOWN, QU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10597018 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031973, K033158, K090658, K963618. One submission often covers many models, so check the product and lot details in each record.

• Z-2451-2015 · Jul 29, 2015 · Terminated
  Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as th
• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.