NA 391.21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982198228), received between Nov 28, 2018 and Jul 17, 2019 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTIFIED THAT THERE WERE A NUMBER OF INSTRUMENTS THAT ARE NOT FUNCTIONING PROPERLY OR DAMAGED: ONE (1) SCREWDRIVER SHAFT CANNULATED CRACKED TIP AND CANNOT FIT INTO SCREW HOLE, ONE (1) WIRE TIGHTENER WOOD HANDLE, THE HANDLE WAS BROKEN IN TWO AND FALLEN OFF, ONE (1) DEPTH GAUGE WITH MEASURING PROBE SNAPPED OFF AND WAS NOT RECOVERED. IT IS UNKNOWN IF WHEN WAS THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE A PROCEDURE AND PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798172 ↗
• MalfunctionMar 8, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2019, DURING ORTHOPEDIC PROCEDURE, HANDLE OF WIRE TIGHTENER WITH HANDLE BROKE. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) WIRE TIGHTENER WITH HANDLE & TWO PEGS 240MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8403957 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A WIRE TIGHTENER HANDLE WAS FOUND BROKEN WHEN THE FACILITY OPENED A TRAY. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) WIRE TIGHTENER WITH HANDLE & TWO PEGS 240MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8127153 ↗
• MalfunctionNov 28, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, A HANDLE OF THE WIRE TIGHTENER WAS FOUND BROKEN. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) WIRE TIGHTENER WITH HANDLE & TWO PEGS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8113493 ↗