NA 144110Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00848486018160), received between Aug 30, 2019 and Apr 1, 2020 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionApr 1, 2020Break; Fracture; Break; Fracture

  THE SURGEON STARTED REMOVING THE 4 X 110 TIBIAL PIN AND IT BROKE OFF IN THE PATIENT'S TIBIA. HE DECIDED TO LEAVE IT IN PLACE, COMMENTING THAT IT SHOULD BE AN ISSUE SINCE IT WAS BURIED. CASE TYPE: TKA.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9911496 ↗
• InjuryFeb 25, 2020Break; Fracture; Break; Fracture

  WHEN TRYING TO REMOVE THE BONE PINS FROM THE PATIENT AT THE END OF THE PROCEDURE THE TIBIAL BONE BROKE. FLURO WAS CALLED INTO ROOM TO REVEAL THAT THE BONE PIN WAS HIT AND BENT DURING WHILE PERFORMING THE TIBIAL KEEL PUNCH. THE SURGEON OPTED TO LEAVE THE BROKEN PIN IN THE PATIENT. CASE TYPE: TKA SURGICAL DELAY15 MINUTES.

  Patient problems: Bone Fracture(s); Foreign Body In Patient

  MAUDE report 9750249 ↗
• MalfunctionJan 28, 2020Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  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 9636345 ↗
• MalfunctionJan 13, 2020Break; Fracture; Break; Fracture

  TIP OF PIN BROKE OFF INTO THE PATIENT. CASE TYPE: TKA. SURGICAL DELAY: > 30 MINUTES.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9583885 ↗
• MalfunctionJan 8, 2020Difficult to Remove; Difficult to Remove

  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 9566696 ↗
• MalfunctionDec 11, 2019Fracture; Fracture

  THE SURGEON BEGAN TO MANUALLY REAM THE TIBIA FOR A UNIVERSAL BASEPLATE WITH PRESSFIT STEM, WHEN REMOVING THE TIBIAL BONE PINS FOR THE ARRAY ASSEMBLY ONE OF THE BONE PINS BROKE INSIDE THE PATIENT. USING X-RAY THE SURGEON WAS ABLE TO LOCATE THE BONE PIN FIXED INSIDE CORTICAL BONE AND WAS UNABLE TO RETRIEVE IT. CASE TYPE: TKA. SURGICAL DELAY: = 15 MINUTES.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9453219 ↗
• MalfunctionAug 30, 2019Break; Non Reproducible Results; Break; 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 8952182 ↗