NA 329.151Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982191854), received between Dec 16, 2016 and Mar 26, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FINLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE OPERATION, THE LAP PLATE WAS CUT AND AT THE SAME TIME THE CUTTER'S "JAW "SUDDENLY BROKE. A SECOND CUTTER WAS USED AND THE PROCEDURE CONTINUED UNINTERRUPTED. THIS REPORT INVOLVES ONE (1) LOCKING CALCANEAL PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18979154 ↗
• MalfunctionMar 31, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT SENT DOWN FROM THE OR SURGEON CUT PLATE, AND DURING CUTTING NOTICED TIP OF CUTTER SEPARATED FROM HANDLE AND INSERT SCREW WAS BENT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658134 ↗
• MalfunctionFeb 9, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PLATE CUTTER WAS BROKEN. IT APPEARED TO HAVE SHEERED INTO TWO PIECES. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501646 ↗
• MalfunctionMay 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE NON-ACCEPTANCE OF THE INSTRUMENT WITH CABLE IN CELERON MATERIAL BY THE (B)(6), WE CONSULTED WITH NURSE (B)(6), RESPONSIBLE FOR THE TECHNICAL AREA OF THE HOSPITAL'S MATERIALS CENTER. IT IS A MATERIAL THAT HAS POROSITY DUE TO EXPOSURE TO THE TEMPERATURE OF THE STERILIZATION PROCESS. IT IS THE POROSITY OF THE CELERON THAT COMPROMISES THE CLEANING PROCESS. IT WAS UNDERSTOOD THEN THAT THE MATERIAL COMPROMISES THE STERILIZATION PROCESS, SINCE IT HAS POROSITY THAT DOES NOT GUARANTEE THE EFFECTIVENESS OF CLEANING. IF YOU ARE NOT IN ACCORDANCE WITH THE JUSTIFICATION PRESENTED, I SUGGEST THAT YOU PRESENT TO THE HOSPITAL TECHNICIANS RESPONSIBLE, A DOCUMENT WITH THE MANUFACTURER'S SPECIFICATIONS THAT MEET THE STANDARDS OF THE MANUALS OF GOOD CLEANING AND STERILIZATION PRACTICES. THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE CUTTER. THIS IS REPORT 1 OF 15 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862730 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE POSITIONING KNOB OF THE LOCKING CALCANEAL PLATE CUTTER FELL OFF. THE ISSUE WAS FOUND BEFORE DELIVERING A LOANER TRAY TO A HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891319 ↗
• MalfunctionMar 12, 2019Crack; Contamination /Decontamination Problem; Crack; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE HANDLES OF A LOCKING CALCANEAL PLATE CUTTER AND SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE WERE CRACKED AND LEAVE A BROWN STAIN AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE CUTTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8414535 ↗
• MalfunctionOct 19, 2018Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, BEFORE STARTING AN UNKNOWN PROCEDURE AT A MATERIAL CONFERENCE, A CUTTING PLIERS WAS VERIFIED TO HAVE A LATCH MISSING. THIS IS A KEY PIECE THAT FITS THE PLATE SO IT CAN BE CUT. THE DEVICE WAS NOT USABLE. A BOARD CUTTER FROM THE HOSPITAL WAS USED TO REPLACE THE PLIERS WHICH WAS EFFECTIVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO DAMAGE TO THE PATIENT. THIS REPORT IS FOR A LOCKING CALCANEAL PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984464 ↗
• MalfunctionSep 18, 2018Break; Break

  (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT ON (B)(6) 2018, DECONTAMINATION STAFF RECEIVED THE BROKEN LOCKING CALCANEAL PLATE CUTTER FROM OPERATING ROOM (OR). THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE CUTTER. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7886857 ↗
• MalfunctionFeb 10, 2017Break; Dull, Blunt; Break; Dull, Blunt

  (B)(4) REPORTED THAT A PLATE CUTTER WAS DISCOVERED DAMAGED AND COULD NOT BE USED PROPERLY TO CUT THE PLATE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) CALCANEUM ON (B)(6) 2016. THE SURGERY WAS COMPLETED WITH A SIMILAR PRODUCT WITH NO PATIENT HARM OR SURGICAL DELAY. UPON THE RECEIPT OF THE DEVICE AT MANUFACTURER, IT WAS FOUND DURING INVESTIGATION ON JAN 30, 2017, THAT THE RETURNED DEVICE WAS FOUND TO HAVE A BROKEN PLATE HOLDER COMPONENT. ADDITIONALLY THE DISTAL PIN THROUGH THE PLATE HOLDER WAS FOUND LOOSE. CONCOMITANT DEVICE REPORTED: PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6322137 ↗
• MalfunctionDec 16, 2016Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF AN OLECRANON PERFORMED ON (B)(6) 2011, THE PLATE CUTTER BROKE WHEN TRYING TO CUT THE TAB OFF OF THE PLATE. THE EVENT OCCURRED ON THE BACK TABLE, THEREFORE THERE WAS NO DIRECT PATIENT INVOLVEMENT. ANOTHER INSTRUMENT WAS USED TO BEND AND REMOVE THE TAB. THERE WAS APPROXIMATELY A FIVE MINUTE SURGICAL DELAY TO OBTAIN THE ALTERNATE INSTRUMENT. IT IS UNKNOWN IF X-RAYS WERE TAKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT MEDICAL PRODUCTS: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6182461 ↗