NA 112680Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00848486017903), received between Apr 12, 2019 and Feb 27, 2020 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2020Difficult to Insert; Separation Failure; Difficult to Insert; Separation Failure

  MPS REPORTED THAT "EVENT DESCRIPTION: DURING A TOTAL KNEE ARTHROPLASTY (TKA), ONE TIBIAL BONE PIN REFERENCE HAS BEEN STUCK INTO THE 4.0 STABILIZER DURING PINS INSERTION AND FIXATION INTO THE BONE WAS CONSEQUENTLY IMPOSSIBLE AS THE PIN WAS NOT SLIDING ALONG THE STABILIZER (STUCK AT SOME POINT INTO IT). ACTION TAKEN: AS THE SURGEON COULDN¿T INSERT THE PINS ANYMORE, WE OPENED A NEW KNEE TRAY TO GET ANOTHER 4.0 STABILIZER AND ANOTHER PACK OF TIBIAL BONE PINS AND WE COULD PROCEED AGAIN TO THE SURGERY NORMALLY. PATIENT IMPACT: NONE. NO ANESTHESIA EXTENSION NEEDED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9765915 ↗
• MalfunctionFeb 27, 2020Difficult to Remove; Separation Failure; Physical Resistance/Sticking; Difficult to Remove; Separation Failure; Physical Resistance/Sticking

  THE BONE PIN IS STUCK IN THE SHORT ARRAY STABILIZER, IMPOSSIBLE TO EXTRACT. CASE TYPE: TKA, LEFT SIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764840 ↗
• MalfunctionFeb 14, 2020Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  (B)(6) (MPS) REPORTED THAT : "DURING THE FEMORAL TIBIAL PINS, THE TIBIAL PINS STABILIZER AND THE PINS WERE STUCK TOGETHER (PINS REMOVED FROM THE PATIENT AS WELL AS THE PIN STABILIZER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9711028 ↗
• MalfunctionFeb 11, 2020Physical Resistance/Sticking; Separation Problem; Physical Resistance/Sticking; Separation Problem

  PIN GOT STUCK IN PIN STABILIZER. CASE TYPE: TKA. SURGICAL DELAY: <= 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9696040 ↗
• MalfunctionFeb 11, 2020Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  CUSTOMER REPORTED THAT THE PIN JAMMED IN STABILIZER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694885 ↗
• MalfunctionFeb 4, 2020Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  DURING TKA, PIN BECAME STUCK IN STABILIZER. CASE TYPE: TKA. UPDATE: WAS THE BONE PIN IN THE PATIENT WHEN EVENT OCCURRED? YES. DID THE BONE PIN BREAK IN THE PATIENT WHEN THE EVENT OCCURRED? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9663264 ↗
• MalfunctionJan 30, 2020Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  BONE SCREW STUCK IN PIECE. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9646747 ↗
• MalfunctionJan 30, 2020Separation Failure; Separation Failure

  WHILE DRILLING INTO BONE, BONE PIN BECAME STUCK INTO BONE STABILIZER AND WILL NOT COME OUT. CASE TYPE: TKA. SURGICAL DELAY: X <= 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9646688 ↗
• MalfunctionJan 28, 2020Difficult to Remove; Separation Problem; Difficult to Remove; Separation Problem

  THE CUSTOMER REPORTED THAT THE 110MM X4MM TIBIAL BONE PIN BECAME STUCK IN THE 4MM BONE PIN STABILISER. WHEN TRYING TO REMOVE THE PIN FROM THE PATIENT AT THE END OF SURGERY THE PINS THREAD WAS LOST SO THE DRILL WAS UNABLE TO REMOVE AND IT BECAME WEDGED IN THE STABILISER. THIS RESULTED IN TWO ADDITION MANUAL KITS BEING OPENED IN ORDER TO ACCESS TOOLS TO ENABLE THE SURGEON TO REMOVE THE PIN. THIS WAS DONE WITH NO HARMFUL CONSEQUENCES TO THE PATIENT ALTHOUGH DID DELAY THE SURGERY SLIGHTLY. UPDATE: NO UNINTENDED METAL DEBRIS FROM THE THREADS FELL INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9636406 ↗
• MalfunctionJan 8, 2020Difficult to Remove; Separation Problem; Difficult to Remove; Separation Problem

  4.0 X 110MM PIN BECAME STUCK IN THE SHORT 4.0 ARRAY STABILIZER WHEN THE SURGEON ATTEMPTED TO REMOVE THE PIN FROM THE BONE. THE PIN WAS REMOVED FROM THE BONE BY MANUALLY. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9566584 ↗
• MalfunctionAug 30, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  SALES REP REPORTED THAT WHEN INSERTING A 4X 110 PIN ( LOT W63530 CODE 114110) INTO PIN STABILISER ( CODE 112680 LOT 19050915) PIN BENT AND SNAPPED IN STABILISER. SYSTEM 6 WAS REQUIRED TO REMOVE PIN . NEW PIN HAD TO BE USED WITH NEW STABILISER. THE PROCEDURE WAS A LEFT MAKO UNICOMPARTMENTAL KNEE REPLACEMENT. THERE WAS A DELAY OF 10 MINUTES. CASE TYPE: PKA. SURGICAL DELAY: 10 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8952226 ↗
• MalfunctionApr 12, 2019Material Deformation; Non Reproducible Results; Material Deformation; Non Reproducible Results

  4.0 BONE PIN STUCK IN 4.0 SHORT PIN STABILIZER. NOTICED WHEN EXPLANTING A TIBIAL 4.0 BONE PIN, IT BECAME STUCK IN THE STABILIZER. AT THE END OF THE CASE, WE TOOK A METAL CUTTING BURR AND CUT THE STABILIZER SO THAT IT COULD BE REMOVED FROM THE PATIENT¿S TIBIA. CASE TYPE: PKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8508323 ↗