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NA 210040Recalls & reported problems

Mako Surgical Corp. · RAIL CLAMP · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486031831), received between Mar 15, 2019 and Dec 11, 2020 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break4
  • Fracture2
  • Detachment of Device or Device Component1
  • Mechanical Problem1

Patient problems

  • No Known Impact Or Consequence To Patient3
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 11, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    BREAKING OF THE RETAINING RING OF THE LOCKING SCREW (SLIDER FIXING THE LEG HOLDER TO THE OPERATING BED).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10992828 ↗
  • MalfunctionMay 22, 2019Break; Fracture; Break; Fracture

    WHILE ATTACHING THE STRYKER LEG POSITIONER CLAMP TO THE BED RAIL, 2 PIECES OF THE CLAMP BROKE OFF AND WE WERE UNABLE TO REPAIR OR USE THE INSTRUMENT. WE WERE ABLE TO RETRIEVE THE BROKEN PIECES. THE SAME THING HAPPENED TO A SECOND CLAMP, ISSUING ANOTHER PER FOR THAT ONE. CASE TYPE: TKA. SURGICAL DELAY: 15 MINUTES, PATIENT WAS UNDER ANESTHESIA. WAS THE PATIENT UNDER ANESTHESIA DURING THE SURGICAL DELAY? "YES PATIENT WAS UNDER ANESTHESIA BUT THE PROCEDURE HAD NOT STARTED YET". DID THIS OCCUR DURING LEG POSITIONING, AND DID THE LEG FALL OFF THE TABLE WHEN THE RAIL CLAMP BROKE? "YES HE WAS ATTEMPTING TO ATTACH THE CLAMP TO THE BED RAIL BUT THERE WAS NO IMPACT TO THE PATIENTS LEG OR ANYTHING ON THE PATIENT AT ALL".

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8632963 ↗
  • MalfunctionMay 22, 2019Break; Fracture; Break; Fracture

    WHILE ATTACHING THE STRYKER LEG POSITIONER CLAMP TO THE BED RAIL, 2 PIECES OF THE CLAMP BROKE OFF AND WE WERE UNABLE TO REPAIR OR USE THE INSTRUMENT. WE WERE ABLE TO RETRIEVE THE BROKEN PIECES. THIS WAS THE SECOND CLAMP THIS HAPPENED TO IN THE SAME CASE. REFERENCE (B)(4) FOR 1ST EVENT. CASE TYPE: TKA SURGICAL DELAY: =15 MINUTES 1. WAS THE PATIENT UNDER ANESTHESIA? "YES PATIENT WAS UNDER ANESTHESIA BUT THE PROCEDURE HAD NOT STARTED YET". 2. DID THE LEG FALL OFF THE TABLE? "YES HE WAS ATTEMPTING TO ATTACH THE CLAMP TO THE BED RAIL BUT THERE WAS NO IMPACT TO THE PATIENTS LEG OR ANYTHING ON THE PATIENT AT ALL".

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8632859 ↗
  • MalfunctionMar 15, 2019Break; Mechanical Problem; Break; Mechanical Problem

    DURING A TKA THE SURGEON WAS INTERNALLY ROTATING THE LEG AND CLAMP BROKE. CASE TYPE: TKA. SURGICAL DELAY: 5-10 MINUTES. DID THE LEG FALL OFF THE TABLE? AS PER THE MPS: YES, IT DID FALL ON THE TABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8424115 ↗

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Sources and updates

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