NA 210060Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00848486031855), received between Mar 12, 2019 and Mar 18, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (8 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

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2020Degraded; Material Frayed; Degraded; Material Frayed

  F-BAR IS BEGINNING TO SPLINTER . CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9850208 ↗
• MalfunctionFeb 26, 2020Material Frayed; Material Frayed

  CPD ALERTED ME THAT THE F BAR USED WITH THE MAKO BLACK LEG HOLDER WAS CHIPPING AWAY WHERE THE SLED GLIDE'S AND CLAMPS DOWN ON. THERE WAS SOME SPLINTERING AND NOW THEY ARE CONCERNED WITH STRUCTURAL INTEGRITY, PATIENT, AND EMPLOYEE SAFETY WITH THE PART AND WOULD LIKE TO HAVE IT REPLACED. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9758236 ↗
• MalfunctionJan 10, 2020Crack; Material Frayed; Sharp Edges; Crack; Material Frayed; Sharp Edges

  STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. UPDATE : HOW MANY SURGERIES WERE INVOLVED WITH THE REPORTED ISSUE? APPROXIMATELY 300 PROCEDURES TO GET TO THIS POINT. ALL THE REPORTED DEVICES THAT ARE INCLUDED IN THIS COMPLAINT WERE FOR ONE OR MANY SURGERIES? MANY ¿ SPD CALLED US CONCERNED ABOUT EXPOSED FIBERS AND CRACKS. HAVE YOU REPORTED EACH INCIDENT SEPARATELY THAT HAS THE ISSUES YOU HAVE MENTIONED IN THIS COMPLAINT? (IF NO, PLEASE SUBMIT A COMPLAINT FOR EACH ISSUE.) NO ¿ MULTIPLE LEG HOLDERS ARE EXHIBITING WEAR. THE ITEMS LISTED IN THE PER EITHER HAVE EXPOSED FIBERS OR CRACKS. PLEASE CONFIRM IF THERE WAS A PATIENT THAT WAS ¿STUCK¿ BY THE EXPOSED CARBON FIBER? NOT A PATIENT ¿ A STAFF MEMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9577641 ↗
• MalfunctionJan 10, 2020Crack; Material Frayed; Sharp Edges; Crack; Material Frayed; Sharp Edges

  STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. COMMENT WAS MADE BY SPD MANAGER BARBARA WILLIAMS, DURING A CONVERSATION. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. UPDATE : HOW MANY SURGERIES WERE INVOLVED WITH THE REPORTED ISSUE? APPROXIMATELY 300 PROCEDURES TO GET TO THIS POINT. ALL THE REPORTED DEVICES THAT ARE INCLUDED IN THIS COMPLAINT WERE FOR ONE OR MANY SURGERIES? MANY ¿ SPD CALLED US CONCERNED ABOUT EXPOSED FIBERS AND CRACKS. HAVE YOU REPORTED EACH INCIDENT SEPARATELY THAT HAS THE ISSUES YOU HAVE MENTIONED IN THIS COMPLAINT? (IF NO, PLEASE SUBMIT A COMPLAINT FOR EACH ISSUE.) NO ¿ MULTIPLE LEG HOLDERS ARE EXHIBITING WEAR. THE ITEMS LISTED IN THE PER EITHER HAVE EXPOSED FIBERS OR CRACKS. PLEASE CONFIRM IF THERE WAS A PATIENT THAT WAS ¿STUCK¿ BY THE EXPOSED CARBON FIBER? NOT A PATIENT ¿ A STAFF MEMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9577462 ↗
• MalfunctionJan 10, 2020Crack; Material Frayed; Sharp Edges; Crack; Material Frayed; Sharp Edges

  STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. UPDATE : HOW MANY SURGERIES WERE INVOLVED WITH THE REPORTED ISSUE? APPROXIMATELY 300 PROCEDURES TO GET TO THIS POINT. ALL THE REPORTED DEVICES THAT ARE INCLUDED IN THIS COMPLAINT WERE FOR ONE OR MANY SURGERIES? MANY ¿ SPD CALLED US CONCERNED ABOUT EXPOSED FIBERS AND CRACKS. HAVE YOU REPORTED EACH INCIDENT SEPARATELY THAT HAS THE ISSUES YOU HAVE MENTIONED IN THIS COMPLAINT? (IF NO, PLEASE SUBMIT A COMPLAINT FOR EACH ISSUE.) NO ¿ MULTIPLE LEG HOLDERS ARE EXHIBITING WEAR. THE ITEMS LISTED IN THE PER EITHER HAVE EXPOSED FIBERS OR CRACKS. PLEASE CONFIRM IF THERE WAS A PATIENT THAT WAS ¿STUCK¿ BY THE EXPOSED CARBON FIBER? NOT A PATIENT ¿ A STAFF MEMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9577444 ↗
• MalfunctionJan 10, 2020Crack; Material Frayed; Sharp Edges; Crack; Material Frayed; Sharp Edges

  STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. UPDATE : HOW MANY SURGERIES WERE INVOLVED WITH THE REPORTED ISSUE? APPROXIMATELY 300 PROCEDURES TO GET TO THIS POINT. ALL THE REPORTED DEVICES THAT ARE INCLUDED IN THIS COMPLAINT WERE FOR ONE OR MANY SURGERIES? MANY ¿ SPD CALLED US CONCERNED ABOUT EXPOSED FIBERS AND CRACKS. HAVE YOU REPORTED EACH INCIDENT SEPARATELY THAT HAS THE ISSUES YOU HAVE MENTIONED IN THIS COMPLAINT? (IF NO, PLEASE SUBMIT A COMPLAINT FOR EACH ISSUE.) NO ¿ MULTIPLE LEG HOLDERS ARE EXHIBITING WEAR. THE ITEMS LISTED IN THE PER EITHER HAVE EXPOSED FIBERS OR CRACKS. PLEASE CONFIRM IF THERE WAS A PATIENT THAT WAS ¿STUCK¿ BY THE EXPOSED CARBON FIBER? NOT A PATIENT ¿ A STAFF MEMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9577443 ↗
• MalfunctionDec 23, 2019Degraded; Material Frayed; Degraded; Material Frayed

  CPD NOTIFIED ME OF SPLINTERED LONG RAIL ON LEG POSITIONER. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9510914 ↗
• MalfunctionOct 31, 2019Crack; Material Integrity Problem; Crack; Material Integrity Problem

  CARBON FIBER COATING ON THE BASE BAR IS CHIPPED FROM USE. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9260072 ↗
• MalfunctionOct 2, 2019Material Frayed; Material Deformation; Material Integrity Problem; Material Frayed; Material Deformation; Material Integrity Problem

  SPLINTERING IN THE BLACK LEG HOLDER HAS OCCURRED AND GAVE EMPLOYEE IN CPD SPLINTERS (CARBON FIBER) THAT HAS CAUSED CONCERN AS TO THE STRUCTURAL INTEGRITY OF THE DEVICE AND IF FURTHER SPLINTERING COULD OCCUR IN THE OR AND AFFECT THE PATIENT. WOULD LIKE ALL CARBON PIECES REPLACED (CREATING INDIVIDUAL COMPLAINTS PER PIECE). IN THE CASE OF THE LONG BAR AND EXTENSION BAR THERE IS ALSO CONCERN OF BIO- BURDEN FALLING INTO SMALL HOLES FOUND IN THE BAR. CASE TYPE: TKA.

  Patient problems: Tissue Damage

  MAUDE report 9147807 ↗
• MalfunctionAug 6, 2019Material Deformation; Non Reproducible Results; Material Deformation; Non Reproducible Results

  GAUGES ON SIDE OF LEG HOLDER BASE BAR- CAN YOU PLEASE SHIP OVERNIGHT? CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864787 ↗
• MalfunctionMay 16, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  SCRUB TECH NOTICED SPLINTERING OF CARBON FIBER, ON BASE AND EXTENSION, WHILE INSTALLING THEM. CASE TYPE: TKA. UPDATE: "YES. PATIENT WAS UNDER ANESTHESIA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8617558 ↗
• MalfunctionMar 18, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  THE BASE BAR AT (B)(6) HOSPITAL HAS EXPOSED CARBON FIBERS . CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8429409 ↗
• MalfunctionMar 18, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  THE BASE BAR (PART NUMBER210060) IN THE NEW STRYKER LEG HOLDER HAD EXPOSED CARBON FIBERS WHEN REMOVED FROM PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8429407 ↗
• MalfunctionMar 18, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  THE BASE BAR (PART NUMBER 210060) ARRIVED AND WHEN REMOVED FROM PACKAGING HAD EXPOSED CARBON FIBERS. THIS WAS A NEW PRODUCT TO REPLACE THE BASE BAR FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8427806 ↗
• MalfunctionMar 12, 2019Material Integrity Problem; Material Integrity Problem

  BLACK RAIL GUIDE IS BECOMING WORN FROM USE, RESULTING IN A ROUGH SURFACE ALONG THE CARBON AND SPLINTERING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412717 ↗