NA 210191Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00848486031909), received between Aug 7, 2018 and Nov 15, 2019 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2019Dent in Material; Material Deformation; Material Integrity Problem; Dent in Material; Material Deformation; Material Integrity Problem

  BENT AND GOUGED HOMAN. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9327694 ↗
• MalfunctionNov 15, 2019Dent in Material; Material Deformation; Material Integrity Problem; Dent in Material; Material Deformation; Material Integrity Problem

  BENT AND GOUGED HOMAN. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9327693 ↗
• MalfunctionOct 30, 2019Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  BENT AND GOUGED. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9258414 ↗
• MalfunctionOct 30, 2019Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  BENT AND GOUGED. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9258412 ↗
• MalfunctionOct 30, 2019Dent in Material; Material Integrity Problem; Dent in Material; Material Integrity Problem

  BENT AND GOUGED. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9258405 ↗
• MalfunctionSep 12, 2019Material Integrity Problem; Material Integrity Problem

  HOHMAN RETRACTOR BADLY DAMAGED - NOT ABLE TO BE USED. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9007946 ↗
• MalfunctionJul 8, 2019Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  GAUGED RETRACTOR FROM SAW BLADE FOUND IN CPD. CASE TYPE: NO ASSOCIATED PROCEDURE. UPDATE ON 7/3/2019: WHEN DID THE RETRACTORS BECAME DAMAGED, DURING THE PROCEDURE OR IN CPD? DURING A PROCEDURE DUE TO THE SAW HITTING THE BLADE DURING CUTTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8769331 ↗
• MalfunctionJun 26, 2019Material Integrity Problem; Material Integrity Problem

  GAUGED RETRACTORS FOUND IN CPD WHILE PROCESSING. CASE TYPE: NO ASSOCIATED PROCEDURE. UPDATE: "THE RETRACTORS GET GAUGED AFTER PERFORMING SEVERAL MAKO CASES DUE TO THE SAW BLADE HITTING THEM DURING CUTTING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8736496 ↗
• MalfunctionApr 15, 2019Device Damaged by Another Device; Material Integrity Problem; Device Damaged by Another Device; Material Integrity Problem

  RETRACTOR FOUND IN CPD. CASE TYPE: NO ASSOCIATED PROCEDURE. CAN WE CONFIRM WHEN THE RETRACTORS BECAME DAMAGED? DURING THE PROCEDURE OR IN CPD? AS PER THE MPS " I CANNOT 100 PERCENT CONFIRM BECAUSE I AM NOT INFORMED THEY ARE DAMAGED UNTIL CPD LETS ME KNOW. BY EXAMINING THE RETRACTORS, IT APPEARS THEY ARE BEING DAMAGED DURING THE CASE BECAUSE OF THE GAUGES (I DO NOT KNOW HOW THESE GAUGES WOULD APPEAR FROM CPD). MY GUESS IS THAT THE SAW IS HITTING THE RETRACTORS DURING THE BONE CUTTING PROCESS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8515272 ↗
• MalfunctionApr 4, 2019Material Deformation; Non Reproducible Results; Material Deformation; Non Reproducible Results

  BADLY GAUGED RETRACTOR FOUND IN CPD. CASE TYPE: NO ASSOCIATED PROCEDURE AS PER THE MPS: I DO NOT KNOW WHEN EXACTLY THE RETRACTOR GOT GAUGED BECAUSE IT WAS FOUND ON THE CLEAN SIDE OF CPD AFTER THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485735 ↗
• MalfunctionFeb 19, 2019Material Integrity Problem; Material Integrity Problem

  BADLY GAUGED RETRACTOR. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351758 ↗
• MalfunctionJan 30, 2019Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  THE RETRACTOR HAS A SHARP BURR ON IT. IT MOST LIKELY GOT NICKED BY THE SAW. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288834 ↗
• MalfunctionOct 30, 2018Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

  RETRACTOR WAS SEVERELY DAMAGED DURING CUTTING. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8020225 ↗
• MalfunctionOct 5, 2018Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  BENT HOHMANN RETRACTOR HAS BEEN DAMAGED DUE TO USE. REPLACEMENT NEEDED. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7938597 ↗
• MalfunctionOct 2, 2018Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

  FOUND DAMAGED RETRACTOR IN CPD- HAS GAUGES FROM SAW BLADE. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7925909 ↗
• MalfunctionAug 7, 2018Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  RETRACTOR BADLY DAMAGED DUE TO SAW HITTING IT. PER THE MPS, ALL THE RETRACTORS WERE DAMAGED AND RIGID. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756691 ↗
• MalfunctionAug 7, 2018Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  RETRACTOR BADLY DAMAGED DUE TO SAW HITTING IT. PER THE MPS, ALL THE RETRACTORS WERE DAMAGED AND RIGID. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756685 ↗
• MalfunctionAug 7, 2018Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  RETRACTOR BADLY DAMAGED DUE TO SAW HITTING IT. PER THE MPS, ALL THE RETRACTORS WERE DAMAGED AND RIGID. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756682 ↗
• MalfunctionAug 7, 2018Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  RETRACTOR BADLY DAMAGED DUE TO SAW HITTING IT. PER THE MPS, ALL THE RETRACTORS WERE DAMAGED AND RIGID. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756675 ↗
• MalfunctionAug 7, 2018Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  RETRACTOR BADLY DAMAGED DUE TO SAW HITTING IT. PER THE MPS, ALL THE RETRACTORS WERE DAMAGED AND RIGID. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756672 ↗