NA 03.221.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982076717), received between Jan 7, 2021 and Jun 2, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break

  IT WAS REPORTED ON 10 MAY 2026 THAT THE CABLE CUTTER FROM THE CABLE SET BROKE DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 25360869 ↗
• MalfunctionJan 14, 2026Break; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT GRAPHICS CASES AND INSTRUMENTS ARE CHIPPING AND SHOWING SIGNS OF CORROSION OR WEAR AND BREAKING DOWN SO THE CSPD DEPARTMENT REFUSES TO REPROCESS THEM. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066523 ↗
• MalfunctionJan 13, 2026Break; Corroded; Material Discolored

  IT WAS REPORTED THAT GRAPHICS CASES AND INSTRUMENTS ARE CHIPPING AND SHOWING SIGNS OF CORROSION OR WEAR AND BREAKING DOWN; THE CSPD DEPARTMENT REFUSES TO REPROCESS THEM. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053648 ↗
• MalfunctionDec 15, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DEVICE WAS UNABLE TO BE STERILIZED/ASSEMBLED. DEVICE WAS CHIPPED AND CRACKED; UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804976 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES CONSULTANT FOUND A COUPLE BROKEN INSTRUMENTS. THE SALES ASSOCIATE WAS UNSURE AS TO HOW OR WHEN THE INSTRUMENTS BROKE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1 BLADE FOR CABLE CUTTER THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18702851 ↗
• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) BLADE FOR CABLE CUTTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526978 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CABLE CUTTER WAS BROKEN DURING SURGERY. AN OLD CUTTER WAS USED TO COMPLETED THE PROCEDURE. THERE WAS A DELAY OF 2 MINUTES AS A RESULT OF THIS EVENT. THIS REPORT INVOLVES ONE BLADE FOR CABLE CUTTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519074 ↗
• MalfunctionJun 23, 2021Failure to Cut; Mechanical Jam; Failure to Cut; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING TOTAL HIP REPLACEMENT, THE CABLE CUTTER STOP CUTTING, GET STUCK AND WILL NOT CUT CABLES. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE PROXIMAL THREADS ON THE INNER BLADE ARE DEFORMED. THIS DEVICE CONDITION WAS DETERMINED TO BE REPORTABLE ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) BLADE FOR CABLE CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053840 ↗
• MalfunctionJan 7, 2021Break; Break

  THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135319 ↗
• MalfunctionJan 7, 2021Break; Break

  THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135317 ↗
• MalfunctionJan 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ORTHOPEDIC PROCEDURE OF THE PROXIMAL FEMUR A COLLINEAR CLAMP AND AN IMPACTOR HAD AN UNKNOWN ALLEGATION ALONG WITH THE TWO (2) BROKEN CUTTER. THERE WAS NO SURGICAL DELAY. A DIFFERENT SET WAS USED. THERE WERE NO FRAGMENTS GENERATED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM. THIS REPORT IS FOR ONE (1) BLADE FOR CABLE CUTTER THIS IS REPORT 3 OF 5 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135306 ↗