NA 309.190Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982185662), received between Aug 1, 2017 and Sep 11, 2025 — classified as 12 malfunctions.

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

• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE DURING USE ON AN UNKNOWN DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028153 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEM CAME APART DURING CASE.

  Patient problems: Insufficient Information

  MAUDE report 21919047 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGICAL PROCEDURE FOR POST RIGHT ELBOW IRRIGATION & DEBRIDEMENT, BURSECTOMY, REMOVAL OF HARDWARE, THE TREPHINE BROKEN SCREW INSTRUMENT BROKE WHEN TRYING TO TAKE OUT A K-WIRE. THE SURGEON WAS AWARE, FLUOROSCOPY WAS USED THROUGHOUT CASE TO ENSURE NO BROKEN PIECES LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912671 ↗
• MalfunctionNov 26, 2024

  DURING THE SURGICAL PROCEDURE, THE TREPHINE BROKEN SCREW INSTRUMENT BROKE WHEN TRYING TO TAKE OUT A K-WIRE. SURGEON AWARE, FLUOROSCOPY USED THROUGHOUT CASE TO ENSURE NO BROKEN PIECES LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20781850 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT ON AUG 27, 2024 THE METAL BROKE OFF ON THE REAMER DURING A CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200327 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A HARDWARE REMOVAL OF AN UNKNOWN PROXIMAL FEMUR PLATING CONSTRUCT, A COUPLE OF UNKNOWN SCREW REMOVAL EXTRACTORS WERE BROKEN AND DAMAGED. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED. THERE WAS UNKNOWN SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) EXTRACTION BOLT FOR 2.0MM SCREWS. THIS REPORT IS 5 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870398 ↗
• MalfunctionAug 3, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE BY THE LOAN KIT TECHNICIAN DURING A LOAN KIT INSPECTION THAT THE EXTRACTING END OF THE CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREW AND THE EXTRACTION BOLT FOR 2.0MM SCREWS HAVE SNAPPED OFF. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 2.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10357281 ↗
• MalfunctionDec 31, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT CAPTURES THE EVENT THAT HAPPENED INTRAOPERATIVELY WHEREIN EXTRACTION BOLT COULD NOT REMOVE THE BROKEN CORTEX SCREW BODY FROM THE BONE MATRIX AND THE OTHER EXTRACTION BOLT THAT SHEARED THE REMOVED PROXIMAL PART OF THE SCREW AND BECAME DEFECTIVE WILE RELATED COMPLAINT (B)(4) FOR THE EVENT WHEREIN THE CORTEX SCREW BROKE POST-OPERATIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536002 ↗
• MalfunctionDec 4, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS FOUND THAT A PIECE HAS SNAPPED OFF INSIDE THE THREADED AREA OF THE EXTRACTION BOLT. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9413327 ↗
• MalfunctionOct 15, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT INSTRUMENTS WERE FOUND BROKEN IN INSPECTION TIME. THERE IS NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 3 OF 09 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192453 ↗
• MalfunctionDec 19, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, A CANNULATED SCREW PARTIALLY THREADED BROKE UPON INSERTION INTO THE BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. DEVICE WAS RECEIVED BY MANUFACTURER WITH THREE EXTRACTION BOLTS THAT WERE USED TO REMOVE THE BROKEN CANNULATED SCREW AND MAY HAVE FRAGMENTS OF THE SCREW IN THEM. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180196 ↗
• MalfunctionAug 1, 2017Break; Break

  CONCOMITANT DEVICES REPORTED: SPARE REAMER TUBE FOR HOLLOW REAMER (PART# 309.038, LOT# 2670240, QUANTITY 1). SPARE REAMER TUBE FOR HOLLOW REAMER (PART#309.280, LOT# 2028, QUANTITY 1). SPARE REAMER TUBE FOR HOLLOW REAMER (PART#309.280, LOT# 2000015, QUANTITY 1). EXTRACTION BOLT FOR 2.0MM SCREWS (PART# 309.190, LOT# 2025, QUANTITY 1). THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6757588 ↗