NA 03.120.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982074133), received between Sep 18, 2018 and Feb 24, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (29 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO AN ORTHOPEDIC PROCEDURE, WHEN ATTEMPTING TO USE THE TROCAR FOR THE VA CONDYLAR AIMING ARM CANNULAS, THE TROCAR WOULD NOT ATTACH TO THE CANNULAS LIKE IT WAS SUPPOSED TO. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431583 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025, TROCAR W/HANDLE, WOULD NOT INTERFACE WITH SEVERAL GUIDE SLEEVES. THERE WAS NO DELAY TO SURGERY. SURGERY WAS COMPLETE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741818 ↗
• MalfunctionDec 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TROCAR WOULD NOT HOLD ONTO OUTER SLEEVE ANYMORE. CLICKING MECHANISM WILL NOT ENGAGE WITH SLEEVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715498 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR WITH THE SURGEON, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS A SURGICAL DELAY BUT NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728762 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR WITH THE SURGEON, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS A SURGICAL DELAY BUT NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727674 ↗
• MalfunctionJul 3, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  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 22394523 ↗
• MalfunctionMay 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ORIF OF TIBIAL PLATEAU WITH PERCUTANEOUS AIMING ARM, THE SPIKE TROCAR NO LONGER LOCKED ONTO CANNULA, THUS DELAYING THE CASE. FOUND ANOTHER SET WITH NECESSARY INSTRUMENT. THERE WAS A 10 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008647 ↗
• MalfunctionOct 11, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS IDENTIFIED THAT THE INSTRUMENT HAS A DEPRESSED CLIP WHICH STOPS ANOTHER INSTRUMENT (GUIDE SLEEVE 03.120.014) FROM LOCKING INTO PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434169 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 16,2024 THE TROCAR HANDLE FOR USE 03.120.014 WAS BROKEN. THERE WAS NO PATIENT WAS INVOLVED. THIS REPORT IS FOR ONE (1) TROCAR HANDLE FOR USE 03.120.014. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836329 ↗
• MalfunctionDec 21, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 29-NOVEMBER-2023, THE TROCAR HANDLE IN QUESTION WAS FOUND TO BE BROKEN AND WOULD NOT ENGAGE WITH THE SLEEVE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT, THE EVENT WAS DISCOVERED DURING ROUTINE INSPECTION. THIS REPORT IS FOR A TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372685 ↗
• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE TROCAR WITH HANDLE FOR GUIDE SLEEVE WILL NOT LOCK ONTO THE GUIDE AND STAY LOCKED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395686 ↗
• MalfunctionNov 22, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON NOTICED THAT THE TRACER WITH HANDLE FROM THE 4.5MM VA CURVED CONDYLAR SET WAS NOT PROPERLY CLICKING IN TO A COUPLE OF THE LOCKING/NEUTRAL GUIDES. THERE WAS NOTICEABLE WEAR AND TEAR ON THE TROCAR AS WELL AS THE LOCKING/NEUTRAL GUIDES. THIS OCCURRED INTRA-OP, BUT NO PATIENT ISSUES OR SURGICAL DELAYS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847093 ↗
• MalfunctionSep 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE SETTING UP FOR A ORIF DISTAL FEMUR CASE, IT WAS REALIZED THAT THE INSERTION GUIDES ON THE TROCAR WERE NOT LOCKING ON THE TROCAR CORRECTLY. THIS WAS BEFORE THE CASE BEGAN, SO ANOTHER PEEL PACK TROCAR WAS OPENED UP THAT WAS USED FOR THE CASE AND IT WORKED WELL. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363656 ↗
• MalfunctionApr 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 VA-LCP 450 CURVED CONDYLAR PLATE. THE AIMING ARM PORTION OF THE INNER TROCAR 03.120.015 LOT# L586961. IT WILL NOT STAY LOCK IN THE PIPES INSIDE AIMING ARM. THIS POPS RIGHT BACK OUT. CONCOMITANT PRODUCT: UNK - GUIDES/SLEEVES/AIMING: TRAUMA(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE TROCAR HANDLE FOR USE 03.120.014. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14085003 ↗
• MalfunctionOct 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR PROCEDURE, THE TROCAR HANDLE WAS NOT RETAINING THE CANNULAS FOR THE LOCKING/NEUTRAL GUIDE. THE LOCKING/NEUTRAL GUIDES WERE ALSO NOT RETAINING THE AIMING ARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER LOCKING/NEUTRAL GUIDE IN THE SET. THERE WAS A SURGICAL DELAY OF (5) MINUTES. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) TROCAR HANDLE FOR USE 03.120.014. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12722274 ↗
• MalfunctionSep 24, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT, WHEN THE CURVED CONDYLAR PLATE AND THE AIMING ARM WAS ATTACHED, IT WAS NOT ABLE TO ATTACH DUE TO THE STRIPPAGE OF THE SCREW HOLE OF THE PLATE. WHILE USING THE AIMING ARM ON THE NEW UNKNOWN PLATE, THE NEUTRAL SLEEVES WERE NOT CONNECTING TO THE HARPOON. THE PEDIATRIC AIMING ARM WAS OUTRIGGER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TEN(10) MINUTES DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525838 ↗
• MalfunctionApr 19, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A STERILE PROCESSING IT WAS DISCOVERED THAT FOUR (4) THREADED HANDLES FOR PERCUTANEOUS THREADED DRILL GUIDES ARE STRIPPED AND WILL NOT GRAB THREADED DRILL GUIDES, LOCKING MECHANISM OF TWO (2) TROCARS WITH HANDLE IS WORN OUT AND WILL NOT PROPERLY ATTACH TO TROCAR SLEEVES AND THREE (3) HOLLOW GOUGES ARE CHIPPED/BROKEN. NO KNOWN PATIENT INVOLVEMENT REPORTED THIS REPORT IS FOR ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 7 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686757 ↗
• MalfunctionApr 19, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A STERILE PROCESSING IT WAS DISCOVERED THAT FOUR (4) THREADED HANDLES FOR PERCUTANEOUS THREADED DRILL GUIDES ARE STRIPPED AND WILL NOT GRAB THREADED DRILL GUIDES, LOCKING MECHANISM OF TWO (2) TROCARS WITH HANDLE IS WORN OUT AND WILL NOT PROPERLY ATTACH TO TROCAR SLEEVES AND THREE (3) HOLLOW GOUGES ARE CHIPPED/BROKEN. NO KNOWN PATIENT INVOLVEMENT REPORTED THIS REPORT IS FOR ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 2 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686646 ↗
• MalfunctionMar 31, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION IT WAS NOTICED THAT THE QUICK CLICK CONNECTION WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594714 ↗
• MalfunctionSep 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE TROCAR HANDLE IS NOT HOLDING TROCARS LIKE IT SHOULD BE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567934 ↗
• MalfunctionAug 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE LOCKING/NEUTRAL GUIDE OUTER LOCKING TABS NO LONGER LOCK INTO THE BLACK AIMING ARM. THEY HAVE ESSENTIALLY BEEN STRIPPED AND ARE NO LONGER USABLE. THE TROCAR WITH HANDLE LOCKING TABS ARE ALSO STRIPPED AND NO LONGER CONNECT TO THE LOCKING/NEUTRAL GUIDES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431195 ↗
• MalfunctionJun 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCAR HANDLE WAS NOT RETAINING THE GUIDE SLEEVES. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDE SLEEVES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10198205 ↗
• MalfunctionApr 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INSPECTION AT WAREHOUSE, THE TROCAR WITH HANDLE DID NOT CLICK AND DID NOT STAY IN THE SLEEVE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: GUIDES/SLEEVES/AIMING: SLEEVE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9995638 ↗
• MalfunctionMar 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCAR WITH HANDLE WAS NO LONGER ENGAGING WITH LOCKING/NEUTRAL GUIDE AIMING ARM AND WAS FAILING TO RETAIN OR LOCK INTO THE GUIDES. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING/NEUTRAL GUIDE AIMING ARM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879266 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCAR HANDLE DOES NOT STAY ENGAGED IN GUIDE SLEEVE. IT DOES NOT CLICK IN THE 'LOCK' POSITION. THE SLEEVE FALLS OFF. THE SURGERY WAS COMPLETED WITHOUT DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9740790 ↗