Trek TKL1110Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741201455), received between Dec 5, 2023 and Nov 18, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Difficult to Remove; Material Twisted/Bent; Positioning Problem; Difficult to Remove; Material Twisted/Bent; Positioning Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A STEREOTACTIC GUIDANCE BIOPSY PROCEDURE USING THE TREK BONE MARROW KIT. DURING THE PROCEDURE, THE DEVICE BENT AND STUCK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578294 ↗
• InjuryNov 17, 2025Break; Break

  ON (B)(6) 2025, A 16-YEAR-OLD MALE PATIENT UNDERWENT A BONE BIOPSY PROCEDURE USING THE TREK BONE MARROW BIOPSY KIT. DURING PROCEDURE, THE TIP OF THE NEEDLE ALLEGEDLY BROKE OFF IN THE PATIENT'S BONE. IT WAS FURTHER REPORTED THAT THE MANUAL HAND PIECE ALLEGEDLY BROKE WHEN ATTEMPTING TO RETRIEVE THE CORE FROM THE CANNULA POST BIOPSY AND THE BROKEN PIECE WAS LEFT STUCK IN THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF PATIENT UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23566308 ↗
• MalfunctionDec 30, 2024Break; Failure to Obtain Sample; Material Twisted/Bent; Break; Failure to Obtain Sample; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BONE BIOPSY PROCEDURE INTO SCLEROTIC BONE TISSUE, THE CORE ALLEGEDLY FAILED TO COME OUT OF THE NEEDLE. IT WAS FURTHER REPORTED THAT TWO DIFFERENT KIT SIZES WERE USED WITHOUT SUCCESS. REPORTEDLY, THE CANNULA ALLEGEDLY FOUND TO BE BROKEN AND BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034120 ↗
• MalfunctionDec 29, 2024Break; Failure to Obtain Sample; Material Twisted/Bent; Break; Failure to Obtain Sample; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BONE BIOPSY PROCEDURE, THE HEALTH CARE PROFESSIONAL WAS ALLEGEDLY NOT ABLE TO GET THE CORE OUT OF THE NEEDLE. IT WAS FURTHER REPORTED THAT CANNULA ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032886 ↗
• MalfunctionFeb 16, 2024Material Perforation; Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation; Material Perforation; Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation

  IT WAS REPORTED THAT DURING A BONE LESION BIOPSY IN THE SCLEROTIC BONE, THE NEEDLE ALLEGDLY WOBBLED. IT WAS FURTHER THAT THE PROCEDURE WAS THEN STOPPED, AND UPON RELEASE OF THE NEEDLE IT WAS NOTED THAT THE QUICK CONNECT HAD BECOME COMPLETELY DISCONNECTED FROM THE DRILL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722306 ↗
• MalfunctionFeb 7, 2024Device Contamination with Chemical or Other Material; Unintended Movement; Device Contamination with Chemical or Other Material; Unintended Movement

  IT WAS REPORTED THAT DURING A FEMUR BIOPSY PROCEDURE, THE QUICK CONNECT HUB HAD ALLEGEDLY STARTED TO WOBBLE AND LOST THE RPM'S ABOUT FIFTEEN SECONDS INTO DRILLING. IT WAS FURTHER REPORTED THAT ANOTHER TWO SLEEVES WERE OPENED, AND BOTH HAD THE SAME ISSUE AFTER ABOUT THE SAME AMOUNT OF DRILLING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657433 ↗
• MalfunctionFeb 6, 2024Material Perforation; Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation; Material Perforation; Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation

  IT WAS REPORTED THAT DURING A BONE LESION BIOPSY IN THE SCLEROTIC BONE, THE NEEDLE ALLEGEDLY WOBBLED. IT WAS FURTHER THAT THE PROCEDURE WAS THEN STOPPED, AND UPON RELEASE OF THE NEEDLE IT WAS NOTED THAT THE QUICK CONNECT HAD BECOME COMPLETELY DISCONNECTED FROM THE DRILL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650068 ↗
• MalfunctionJan 31, 2024Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation; Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation

  IT WAS REPORTED THAT DURING A SCLEROTIC BONE LESION BIOPSY, THE NEEDLE ALLEGEDLY WOBBLED AND THE QUICK CONNECT BECAME MORE APPARENT AND STARTED ¿CLICKING¿ AND THEN THE STERILE SLEEVE ALLEGEDLY STARTED TO MOVE/DRAG. IT WAS FURTHER REPORTED THAT UPON RELEASE OF THE NEEDLE, IT WAS NOTED THAT THE QUICK CONNECT HAD ALLEGEDLY BECAME COMPLETELY DISCONNECTED FROM THE DRILL. REPORTEDLY, THE PHYSICIAN HAD TO REMOVE THE NEEDLE FROM THE BONE MANUALLY TO OBTAIN THE SAMPLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612079 ↗
• MalfunctionJan 30, 2024Device Contamination with Chemical or Other Material; Unintended Movement; Device Contamination with Chemical or Other Material; Unintended Movement

  IT WAS REPORTED THAT DURING A FEMUR BIOPSY PROCEDURE, THE QUICK CONNECT HUB HAD ALLEGEDLY STARTED TO WOBBLE AND LOST THE RPM'S ABOUT FIFTEEN SECONDS INTO DRILLING. IT WAS FURTHER REPORTED THAT ANOTHER TWO SLEEVES WERE OPENED, AND BOTH HAD THE SAME ISSUE AFTER ABOUT THE SAME AMOUNT OF DRILLING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607499 ↗
• MalfunctionJan 30, 2024Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation; Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation

  IT WAS REPORTED THAT DURING A SCLEROTIC BONE LESION BIOPSY, THE NEEDLE ALLEGEDLY WOBBLED AND THE QUICK CONNECT BECAME MORE APPARENT AND STARTED ¿CLICKING¿ AND THEN THE STERILE SLEEVE ALLEGEDLY STARTED TO MOVE/DRAG. IT WAS FURTHER REPORTED THAT UPON RELEASE OF THE NEEDLE, IT WAS NOTED THAT THE QUICK CONNECT HAD ALLEGEDLY BECAME COMPLETELY DISCONNECTED FROM THE DRILL. REPORTEDLY, THE PHYSICIAN HAD TO REMOVE THE NEEDLE FROM THE BONE MANUALLY TO OBTAIN THE SAMPLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607228 ↗
• MalfunctionJan 22, 2024Material Perforation; Device Contamination with Chemical or Other Material; Premature Separation; Material Perforation; Device Contamination with Chemical or Other Material; Premature Separation

  IT WAS REPORTED THAT DURING A BONE LESION BIOPSY PROCEDURE, THE HUB ALLEGEDLY DISCONNECTED FROM THE DRIVER AFTER THE SECOND PASS. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550463 ↗
• MalfunctionDec 8, 2023Device Contamination with Chemical or Other Material; Premature Separation; Device Contamination with Chemical or Other Material; Premature Separation

  IT WAS REPORTED THAT DURING A SCLEROTIC LESION BIOPSY PROCEDURE, IT WAS HARD TO GET OUT THE TRAYS AND KEEP THEM STERILE ON THE FIELD. IT WAS FURTHER REPORTED THAT THE DRIVER ALLEGEDLY GOT DISCONNECTED FROM THE HUB AFTER TWO PASSES. FURTHERMORE, THE DRIVER WAS TRIED TO BE RE-ENGAGED TO THE QUICK CONNECT ON THE TABLE BUT WAS NOT ABLE TO. REPORTEDLY, IT WAS NOTICED THAT THE BAG HAD ALLEGEDLY SEPARATED FROM THE QUICK CONNECT AND TO NOT PUT BACK ON THE STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290627 ↗
• MalfunctionDec 5, 2023Device Contamination with Chemical or Other Material; Difficult or Delayed Separation; Device Contamination with Chemical or Other Material; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE AT THE RIGHT HIP ACETABULA BONE, THE HUB WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268072 ↗