NA 03.226.039Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982077158), received between Mar 27, 2019 and Jul 29, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A 1.6 GUIDE WIRE WAS PASSED, AND THEN A 3.2 CANNULATED DRILL BIT WAS PASSED. A NOISE WAS HEARD, THE DRILL BIT WAS REMOVED AND IT WAS EVIDENTLY BROKEN. SOME FRAGMENTS OF THE DRILL BIT WERE RECOVERED. THEN THE SPECIALIST REMOVED THE GUIDE WIRE AND IT WAS ALSO BROKEN. IT WAS NOT POSSIBLE TO RECOVER THE PIECE OF KIRCHNER WIRE FROM THE PATIENT'S BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22644818 ↗
• MalfunctionMar 1, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT HOFFA FRACTURE ORIF FOR DISTAL MEDIAL FEMUR WITH HEADLESS COMPRESSION SCREW 4.5. AFTER THE SURGERY, WHEN THE DRILL BIT IN QUESTION WAS BRUSHED, IT WAS FOUND A COTTON-LIKE SUBSTANCE COMING OUT OF THE HOLLOW. COMPONENT ANALYSIS IS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø3.2/1.7 CANN L225 4FLUT F/QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459683 ↗
• MalfunctionApr 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE INSPECTION, IT WAS DETECTED THAT THE ORTHOKIT CAME WITH A BROKEN DRILL BIT. THERE WAS NO IMPACT ON THE PATIENT, ON THE SURGICAL TIME OR ON CHANGING THE SURGICAL METHOD. THIS REPORT INVOLVES ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135291 ↗
• MalfunctionMar 31, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY. BEFORE SURGERY, AN OPERATION STAFF CHECKED THE PRODUCTS IN QUESTION AND FOUND THAT THERE WERE DIRT/WATER DROPS-LIKE-RESIDUES IN THE HOLLOW PART OF EACH PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13958544 ↗
• MalfunctionFeb 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, BLACK POWDER CAME OUT FROM THE HOLLOW PART OF THE CANNULATED DRILL BIT AFTER CLEANSING. THE PRODUCT WAS IN QUESTION FOR A SURGERY ON (B)(6), 2022 AND AN ADDITIONAL PRODUCT WITH THE SAME PRODUCT NUMBER WERE SHIPPED FOR THE SURGERY. THIS REPORT IS FOR ONE (1) DRILL BIT Ø3.2/1.7 CANN L225 4FLUT. THIS IS REORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560845 ↗
• MalfunctionFeb 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, BLACK POWDER CAME OUT FROM THE HOLLOW PART OF THE CANNULATED DRILL BIT AFTER CLEANSING. THE PRODUCT WAS IN QUESTION FOR A SURGERY ON (B)(6) 2022 AND AN ADDITIONAL PRODUCT WITH THE SAME PRODUCT NUMBER WERE SHIPPED FOR THE SURGERY. THIS REPORT IS FOR ONE (1) DRILL BIT Ø3.2/1.7 CANN L225 4FLUT. THIS IS REORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560841 ↗
• MalfunctionDec 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE SURGERY, THE GUIDE WIRE NEEDLES WERE USED, AND ONE OF THEM BECAME CAUGHT INSIDE OF THE DRILL BIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.2MM CANNULATED DRILL BIT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060858 ↗
• MalfunctionMar 27, 2019Break; Break

  (B)(4) SITE. ON (B)(6) 2019 DURING ROUTINE INCOMING INSPECTION OF LOANER SET (B)(4), IT WAS OBSERVED THAT 03.226.039, 3.2MM CANNULATED DRILL BIT, LOT NUMBER U319440 WAS DISCOVERED BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED. A REPLACEMENT DEVICE HAS BEEN ORDERED. NO REPLACEMENT PRODUCT IS REQUIRED. NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8457379 ↗