NA 03.120.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886982074201), received between Sep 18, 2019 and Dec 5, 2025 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (32 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF NOTICED THAT THE THREADS ARE STRIPPED. THIS IS PREVENTING THE HANDLES FROM CONNECTING PROPERLY TO THE SLEEVES THEY ARE SUPPOSED TO CONNECT TO. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729984 ↗
• MalfunctionDec 5, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF NOTICED THAT THE THREADS ARE STRIPPED. THIS IS PREVENTING THE HANDLES FROM CONNECTING PROPERLY TO THE SLEEVES THEY ARE SUPPOSED TO CONNECT TO. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729904 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, 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 AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786856 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, 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 AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786658 ↗
• 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 22729047 ↗
• 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 22726898 ↗
• MalfunctionNov 19, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THE END OF THE HANDLE IS STRIPPED AND WOULD NOT ATTACH TO SLEEVES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724472 ↗
• MalfunctionOct 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE HANDLE 03.120.022 HANDLE FOR PERC THREADED DRILL GUIDES FOR THE VA DISTAL FEMUR AIMING ARM HAS THREADS THAT SPIN THE TROCAR AND NO LONGER ALLOWS A THREADED GUIDE TO SPIN INTO IT. THE PART CAN BE RETURNED. THERE WERE NO ISSUES WITH FINISHING THE CASE. USED THE OTHER PERC HANDLE FOR THE REST OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539597 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE DOES NOT SCREW ON TIGHTLY ENOUGH AND ANOTHER DEVICE HAS BROKEN TIP. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391555 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160461 ↗
• MalfunctionApr 1, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON MAR 14, 2024, HANDLE FOR PERCUTANEOUS THREADED DRILL WAS NOT THREADING PROPERLY INTO THE GUIDES. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) HANDLE F/NOS. 324.203+324.215 THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011120 ↗
• MalfunctionApr 1, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON MAR 14, 2024, HANDLE FOR PERCUTANEOUS THREADED DRILL WAS NOT THREADING PROPERLY INTO THE GUIDES. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) HANDLE F/NOS. 324.203+324.215. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011119 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED A HANDLE FOR PERCUTANEOUS DRILL GUIDE WAS STRIPPED. THE HANDLE NO LONGER THREADS PROPERLY INTO THE DRILL GUIDE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867218 ↗
• 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) HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 7 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320611 ↗
• 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) H&LE FOR PERCUTANEOUS THRD DRILL GUIDES. THIS IS REPORT 2 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320277 ↗
• MalfunctionApr 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION/INTERNAL FIXATION PROCEDURE ON (B)(6), 2023, THE SURGEON WAS THREADING THE H&LE FOR PERCUTANEOUS THRD DRILL GUIDES INTO THE THREADED DRILL GUIDES, AND THE HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES WOULD THREAD BUT NOT RETAIN THE RIGIDNESS THAT THE SURGEON WAS USED TO ACHIEVING. THE SURGERY WAS DELAYED BY FOUR MINUTES DUE TO THE EVENT. A SECOND SET OF INSTRUMENTS WAS OPENED IN ORDER TO OBTAIN ANOTHER PERCUTANEOUS THREADED DRILL GUIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762267 ↗
• MalfunctionNov 11, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A TIBIAL PLATING WITH PERCUTANEOUS INSTRUMENTS PROCEDURE, THE SCREW THREADS WERE DAMAGED, SO IT WAS NOT POSSIBLE TO SCREW THE INSTRUMENT TO THE HANDLE PROPERLY ANYMORE. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781431 ↗
• MalfunctionJun 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE THREADED DRILL GUIDE BECAME STUCK INSIDE OF THE HANDLE. SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675471 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ONE (1) AIMING ARM FOR VA-LCP CONDYLAR PLATE AND ONE (1) HANDLE WAS BROKEN AFTER AN UNKNOWN PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559609 ↗
• MalfunctionJul 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, IT WAS NOTICED THAT THE HANDLES FOR PERCUTANEOUS DRILL GUIDES DO NOT LOCK ONTO THE DRILL GUIDES INCREASING THE COMPLEXITY OF THE CASES. THERE WAS NO SURGICAL DELAY REPORTED AND NO FRAGMENT GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1)H&LE FOR PERCUTANEOUS THRD DRILL GUIDES. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12110260 ↗
• MalfunctionJul 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, IT WAS NOTICED THAT THE HANDLES FOR PERCUTANEOUS DRILL GUIDES DO NOT LOCK ONTO THE DRILL GUIDES INCREASING THE COMPLEXITY OF THE CASES. THERE WAS NO SURGICAL DELAY REPORTED AND NO FRAGMENT GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1)H&LE FOR PERCUTANEOUS THRD DRILL GUIDES. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12110247 ↗
• MalfunctionJul 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, IT WAS NOTICED THAT THE HANDLES FOR PERCUTANEOUS DRILL GUIDES DO NOT LOCK ONTO THE DRILL GUIDES INCREASING THE COMPLEXITY OF THE CASES. THERE WAS NO SURGICAL DELAY REPORTED AND NO FRAGMENT GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12110240 ↗
• 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) HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 6 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686725 ↗
• 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) HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 5 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686700 ↗
• 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) HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 4 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686677 ↗