NA 03.211.420Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982076328), received between Sep 22, 2023 and Oct 27, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. WHEN INSERTING A COMPRESSION WIRE, IT BROKE OFF ABOVE THE BALL. THE BALL WAS GRASPED WITH A NEEDLE HOLDER AND REMOVED BY ROTATING IT IN THE OPPOSITE DIRECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391938 ↗
• MalfunctionNov 27, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PRODUCT FRACTURED IN THE PROCEDURE. THE PATIENT WAS AFFECTED; IT WAS NOT POSSIBLE TO REMOVE THE FRAGMENT FROM THE PATIENT¿S BODY. THIS REPORT INVOLVES ONE 1.6MM COMPRESSION WIRE 20MM THREAD/150MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 18212224 ↗
• MalfunctionSep 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION PROCEDURE FOR A CLAVICULAR DIAPHYSEAL FRACTURE WITH THE COMPRESSION WIRE. AFTER THE SURGEON PLACED THE SECOND PLATE, THERE WAS SOME FLOATATION, SO AFTER THE LATERAL SIDE WAS IN PLACE, A SINGLE COMPRESSION WIRE WAS INSERTED INTO THE MOST DISTAL MEDIAL HOLE AND FIXED. THE SURGEON THEN ATTEMPTED TO REMOVE THE COMPRESSION WIRE TO INSERT THE SCREWS, BUT THE KIRSCHNER PORTION BROKE OFF FROM THE TOP OF THE BALL. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PART WITH PLIERS DUE TO ITS SPHERICAL SHAPE, SO HE USED A STEEL BAR TO CREATE A SQUARE CORNER, WHICH HE WAS ABLE TO REMOVE WITH PLIERS. THE SURGERY TIME WAS SCHEDULED FOR ONE HALF HOUR, BUT WAS EXTENDED BY 75 MINUTES. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THERE WAS NO PROBLEM WITH BONE FIXATION. THIS REPORT INVOLVES ONE 1.6MM COMPRESSION WIRE 20MM THREAD/150MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797916 ↗