NA 03.211.410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982076281), received between Apr 15, 2021 and Sep 17, 2026 — classified as 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50808816 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE COMPRESSION WIRES BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 1.6 COMP WIRE 10 THREAD/150 LENGTH. THIS REPORT IS 2 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671907 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE COMPRESSION WIRES BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 1.6 COMP WIRE 10 THREAD/150 LENGTH. THIS REPORT IS 4 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671898 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE COMPRESSION WIRES BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 1.6 COMP WIRE 10 THREAD/150 LENGTH. THIS REPORT IS 3 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671894 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE COMPRESSION WIRES BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 1.6 COMP WIRE 10 THREAD/150 LENGTH. THIS REPORT IS 1 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671890 ↗