NA 03.120.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982074157), received between Nov 29, 2018 and Mar 10, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NEUTRAL DRILL GUIDE FOR 4.5 CORTEX SCREW AND THRD LCP(TM) DRILL GUIDE F/LCP(TM) DRPS WERE NOT RETAINING TO THE AIMING ARM DURING USE. BOTH DEVICES DISPLAYED THE SAME ISSUE, DESCRIBED AS THE INABILITY TO PERFORM THEIR INTENDED FUNCTION OF HOLDING ANOTHER DEVICE OR POSITION. THERE WAS NO PATIENT IMPACT, NO REPORTED HARM, AND NO SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559909 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NEUTRAL DRILL GUIDE FOR 4.5 CORTEX SCREW AND THRD LCP (TM) DRILL GUIDE F/LCP (TM) DRPS WERE NOT RETAINING TO THE AIMING ARM DURING USE. BOTH DEVICES DISPLAYED THE SAME ISSUE, DESCRIBED AS THE INABILITY TO PERFORM THEIR INTENDED FUNCTION OF HOLDING ANOTHER DEVICE OR POSITION. THERE WAS NO PATIENT IMPACT, NO REPORTED HARM, AND NO SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559908 ↗
• MalfunctionJan 26, 2026Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. DATE OF EVENT (MM/DD/YYYY): - ITEMS IDENTIFIED AT VARIOUS TIMES IN PREOP TESTING OVER THE LAST FEW MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183148 ↗
• MalfunctionJan 26, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING INSPECTION IT WAS FOUND THE DEVICE WAS NOT SNAPPING IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178611 ↗
• MalfunctionJul 3, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP) ALL ITEMS WERE NOTICED PRE-OP BEFORE A PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394522 ↗
• MalfunctionJul 3, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP) - ALL ITEMS WERE NOTICED PRE-OP BEFORE A PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394521 ↗
• MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL SLEEVE DOES NOT PASS FUNCTION TEST (INSERT INTO GUIDE SLEEVE AND VERIFY THAT ALL PARTS LOCK INTO PLACE). THIS ISSUE WAS IDENTIFIED DURING LOAN KIT INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297657 ↗
• MalfunctionJan 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ITEM WAS NOT LOCKING INTO PLACE. IT WAS NO LONGER FUNCTIONAL AND IN NEED OF REPLACEMENT. THIS ISSUE WAS IDENTIFIED DURING PRE-OP TESTING OF THE EQUIPMENT AND DID NOT IMPACT PATIENT OUTCOMES. ALL ITEMS ARE ABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265623 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, IN STERILE PROCESSING, THE DEVICES WERE FOUND TO BE STRIPPED AND NOT THREADING PROPERLY INTO THE HANDLES. THEY ARE NOT LOCKING INTO THE GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) NEUTRAL DRILL GUIDE FOR 4.5MM CORTEX SCREW. THIS IS REPORT 8 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320658 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, IN STERILE PROCESSING, THE DEVICES WERE FOUND TO BE STRIPPED AND NOT THREADING PROPERLY INTO THE HANDLES. THEY ARE NOT LOCKING INTO THE GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) NEUTRAL DRILL GUIDE FOR 4.5MM CORTEX SCREW. THIS IS REPORT 3 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320479 ↗
• MalfunctionDec 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON NOVEMBER 9, 2023, THERE WAS A BROKEN DRILL SLEEVE. NO CONSEQUENCES TO PATIENT. THIS REPORT IS FOR ONE (1) NEUTRAL DRILL GUIDE FOR 4.5 CORTEX SCREW THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249427 ↗
• MalfunctionSep 22, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL GUIDE WAS FOUND FAIR WEAR AND TEAR CONDITION. IT WAS UNKNOWN WHEN AND HOW IT OCCURRED. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) NEUTRAL DRILL GUIDE FOR 4.5MM CORTEX SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512890 ↗
• MalfunctionFeb 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE NEUTRAL DRILL GUIDE WOULD NOT LOCK INTO THE OUTER SLEEVE. THE SURGEON USED BOTH NEUTRAL DRILL GUIDES IN THE SET AND TRIED ALL SIX (6) OF THE OUTER SLEEVES. THERE WAS A SURGICAL DELAY OF TEN (10) TO FIFTEEN (15) MINUTES IN TOTAL WHILE TRIED MULTIPLE SLEEVES TO FIX PROBLEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN TROCAR WITH HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 8 OF 8 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9763220 ↗
• MalfunctionFeb 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE NEUTRAL DRILL GUIDE WOULD NOT LOCK INTO THE OUTER SLEEVE. THE SURGEON USED BOTH NEUTRAL DRILL GUIDES IN THE SET AND TRIED ALL SIX (6) OF THE OUTER SLEEVES. THERE WAS A SURGICAL DELAY OF TEN (10) TO FIFTEEN (15) MINUTES IN TOTAL WHILE TRIED MULTIPLE SLEEVES TO FIX PROBLEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN TROCAR WITH HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 1 OF 8 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9762700 ↗
• MalfunctionNov 29, 2018Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, ON AN UNKNOWN EVENT, A NEUTRAL DRILL GUIDE DID NOT CLICK IN AND ATTACHED APPROPRIATELY. IT APPEARS THAT THE LOCKING PORTION OF THE NEUTRAL GUIDE WAS WARN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116110 ↗