NA 391.990Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587041087), received between Mar 4, 2019 and Sep 17, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ARTICLE DOES NOT CLOSE PROPERLY, SO NO THREADS CAN BE PINCHED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236496 ↗
• MalfunctionJul 27, 2020Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation

  VETERINARY COMPLAINT: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN CASE IT WAS DISCOVERED THAT THE PLATE ROD CUTTER ARE NOT SPRINGING BACK OPEN AFTER USE. THESE CUTTERS PRIMARILY USED WITH TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) AND TO CUT THE THREADED PIN FOR STANDARD JIG. NO FURTHER INFORMATION PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE CUTTING EDGES WERE DULL AND SLIGHTLY DEFORMED ON BOTH JAWS. THIS DEVICE CONDITION WAS REASSESSED AND DETERMINED AS REPORTABLE ON (B)(6) 2020. CONCOMITANT DEVICES REPORTED: KIRSCHNER WIRE (PART # VW3005.15, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR 1 PLATE/ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10329360 ↗
• MalfunctionApr 20, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLATE/ROD CUTTER DID NOT FUNCTION DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE, IT WAS IDENTIFIED THAT ONE OF THE THREE PIVOT SCREWS IS MISSING ON THE PLATE/ROD CUTTER. THIS PRODUCT CONDITION WAS REASSESSED AND DETERMINED AS REPORTABLE ON MARCH 27, 2020. THIS REPORT INVOLVES ONE (1) PLATE/ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9979005 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 8, 2019, DURING TESTING AT SERVICE AND REPAIR, THE CUTTER WAS BROKEN AND DID NOT CUT. THE ISSUE WAS FOUND WHILE RECEIVING LOANER SET IN LOANER DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PLATE/ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8386201 ↗