NA 351.717Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982193926), received between Oct 14, 2024 and Jun 27, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT CABLE LOCKS DIDN¿T WORK AND DIDN¿T FEED CABLES THROUGH. USER WAS NOT SURE IF JAMMED FROM USAGE OR STRIPPED. CUTTERS WERE DULL. 314.468 WAS ALSO INVOLVED WHICH WAS WARPED FROM USAGE AND OVER TORQUING. IT IS UNKNOWN IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THERE WERE NO PATIENT CONSEQUENCES. THIS (B)(4) IS RELATED TO (B)(4). THIS (B)(4) IS CREATED TO CAPTURE THE ADDITIONAL IPS AS THE QUANTITY INVOLVED IS 5 IN (B)(4) FOR THE (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349425 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT CABLE LOCKS DIDN¿T WORK AND DIDN¿T FEED CABLES THROUGH. USER WAS NOT SURE IF JAMMED FROM USAGE OR STRIPPED. CUTTERS WERE DULL. 314.468 WAS ALSO INVOLVED WHICH WAS WARPED FROM USAGE AND OVER TORQUING. IT IS UNKNOWN IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THERE WERE NO PATIENT CONSEQUENCES. THIS (B)(4) IS RELATED TO (B)(4). THIS (B)(4) IS CREATED TO CAPTURE THE ADDITIONAL IPS AS THE QUANTITY INVOLVED IS 5 IN (B)(4) FOR THE IP-02416865.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349079 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT CABLE LOCKS DIDN¿T WORK AND DIDN¿T FEED CABLES THROUGH. USER WAS NOT SURE IF JAMMED FROM USAGE OR STRIPPED. CUTTERS WERE DULL. 314.468 WAS ALSO INVOLVED WHICH WAS WARPED FROM USAGE AND OVER TORQUING. IT IS UNKNOWN IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THERE WERE NO PATIENT CONSEQUENCES. THIS (B)(4) IS RELATED TO (B)(4). THIS (B)(4) IS CREATED TO CAPTURE THE ADDITIONAL IPS AS THE QUANTITY INVOLVED IS 5 IN (B)(4) FOR THE IP-02416865.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22348357 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT CABLE LOCKS DIDN¿T WORK AND DIDN¿T FEED CABLES THROUGH. USER WAS NOT SURE IF JAMMED FROM USAGE OR STRIPPED. CUTTERS WERE DULL. 314.468 WAS ALSO INVOLVED WHICH WAS WARPED FROM USAGE AND OVER TORQUING. IT IS UNKNOWN IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THERE WERE NO PATIENT CONSEQUENCES. THIS (B)(4) IS RELATED TO (B)(4). THIS (B)(4) IS CREATED TO CAPTURE THE ADDITIONAL IPS AS THE QUANTITY INVOLVED IS 5 IN (B)(4) FOR THE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347749 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT CABLE LOCKS DIDN¿T WORK AND DIDN¿T FEED CABLES THROUGH. USER WAS NOT SURE IF JAMMED FROM USAGE OR STRIPPED. CUTTERS WERE DULL. THE SLEEVE WAS ALSO INVOLVED WHICH WAS WARPED FROM USAGE AND OVER TORQUING. IT IS UNKNOWN IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344448 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THERE WERE TWO (2) BROKEN INSTRUMENTS. IT IS UNKNOWN HOW OR WHEN THEY BROKE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440251 ↗
• InjuryOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2024, A BOX OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20439789 ↗