NA 324.203Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886982191205), received between Aug 30, 2017 and Jan 30, 2026 — classified as 29 malfunctions.

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

• MalfunctionJan 30, 2026Break

  IT WAS REPORTED PAINT IS CHIPPING OFF OF OUR INSTRUMENT AND STERILE PROCESSING WILL NOT PROCESS UNTIL RESOLVED. NO PATIENT HARM. THERE IS A SIGNIFICANT DELAY IN BEING ABLE TO PROCESS THE INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222311 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED PAINT IS CHIPPING OFF OF OUR INSTRUMENT AND STERILE PROCESSING WILL NOT PROCESS UNTIL RESOLVED. NO PATIENT HARM. THERE IS A SIGNIFICANT DELAY IN BEING ABLE TO PROCESS THE INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221928 ↗
• 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 22786866 ↗
• 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 22786865 ↗
• 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 22786862 ↗
• 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 22786861 ↗
• 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 22786859 ↗
• 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 22786858 ↗
• 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 22786855 ↗
• 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 22727861 ↗
• MalfunctionJun 16, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, SEVERAL OF THE 4.3MM PERCUTANEOUS THREADED DRILL GUIDE IN THE 4.5MM VA-LCP CURVED CONDYLAR AIMING INSTRUMENTS SET ARE STRIPPED AND DO NOT THREAD ONTO THE HANDLE ANYMORE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17147088 ↗
• 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 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762249 ↗
• MalfunctionFeb 27, 2023Device-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 THAT ON JANUARY 26, 2023, DURING A CASE USING VA CONDYLAR, THE SURGEON COMMENTED THAT THE PERCUTANEOUS DRILL GUIDE WOULD NOT THREAD INTO THE PLATE. THE OTHER DRILL GUIDES IN THE SET WORKED FINE, APPARENTLY AND WILL NEED TO BE REPLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) SECONDS OF SURGICAL DELAY. NO PATIENT CONSEQUENCES AND NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444465 ↗
• 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 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675420 ↗
• MalfunctionJul 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT IT WAS NOT POSSIBLE TO ADAPT THE DRILL BIT GUIDE TO THE HEXAGONAL WRENCH ROD. THEREFORE, IT WAS DIFFICULT TO TIGHTEN IT INTO THE PLATE. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182281 ↗
• MalfunctionMay 4, 2021Device-Device Incompatibility; Material Twisted/Bent; No Apparent Adverse Event; Device-Device Incompatibility; Material Twisted/Bent; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS PERFORMING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMUR USING THE DISTAL CONDYLAR LOCKING PLATES AND THE AIMING ARM. DURING THE PROCEDURE SURGEON WAS HAVING DIFFICULTY GETTING THE LOCKING GUIDES TO ENGAGE WITH THE PLATE AND BELIEVED THE THREADS AT THE TIP OF THE GUIDE WERE WORN. HE TRIED DIFFERENT GUIDES FROM THE SET AND FOUND ONE TO WORK EASIER THAN OTHERS AND USED THAT ONE TO FINISH CASE. THERE WAS SURGICAL DELAY OF TWO-THREE (2-3) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769433 ↗
• MalfunctionApr 30, 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 ON (B)(6) 2021, THE SURGEON WAS PERFORMING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMUR USING THE DISTAL CONDYLAR LOCKING PLATES AND THE AIMING ARM. DURING THE PROCEDURE SURGEON WAS HAVING DIFFICULTY GETTING THE LOCKING GUIDES TO ENGAGE WITH THE PLATE AND BELIEVED THE THREADS AT THE TIP OF THE GUIDE WERE WORN. HE TRIED DIFFERENT GUIDES FROM THE SET AND FOUND ONE TO WORK EASIER THAN OTHERS AND USED THAT ONE TO FINISH CASE. THERE WAS SURGICAL DELAY OF TWO-THREE (2-3) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753837 ↗
• MalfunctionApr 30, 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 ON (B)(6) 2021, THE SURGEON WAS PERFORMING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMUR USING THE DISTAL CONDYLAR LOCKING PLATES AND THE AIMING ARM. DURING THE PROCEDURE SURGEON WAS HAVING DIFFICULTY GETTING THE LOCKING GUIDES TO ENGAGE WITH THE PLATE AND BELIEVED THE THREADS AT THE TIP OF THE GUIDE WERE WORN. HE TRIED DIFFERENT GUIDES FROM THE SET AND FOUND ONE TO WORK EASIER THAN OTHERS AND USED THAT ONE TO FINISH CASE. THERE WAS SURGICAL DELAY OF TWO-THREE (2-3) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753831 ↗
• MalfunctionApr 30, 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 ON (B)(6) 2021, THE SURGEON WAS PERFORMING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMUR USING THE DISTAL CONDYLAR LOCKING PLATES AND THE AIMING ARM. DURING THE PROCEDURE SURGEON WAS HAVING DIFFICULTY GETTING THE LOCKING GUIDES TO ENGAGE WITH THE PLATE AND BELIEVED THE THREADS AT THE TIP OF THE GUIDE WERE WORN. HE TRIED DIFFERENT GUIDES FROM THE SET AND FOUND ONE TO WORK EASIER THAN OTHERS AND USED THAT ONE TO FINISH CASE. THERE WAS SURGICAL DELAY OF TWO-THREE (2-3) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753827 ↗
• MalfunctionApr 30, 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 ON (B)(6) 2021, THE SURGEON WAS PERFORMING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMUR USING THE DISTAL CONDYLAR LOCKING PLATES AND THE AIMING ARM. DURING THE PROCEDURE SURGEON WAS HAVING DIFFICULTY GETTING THE LOCKING GUIDES TO ENGAGE WITH THE PLATE AND BELIEVED THE THREADS AT THE TIP OF THE GUIDE WERE WORN. HE TRIED DIFFERENT GUIDES FROM THE SET AND FOUND ONE TO WORK EASIER THAN OTHERS AND USED THAT ONE TO FINISH CASE. THERE WAS SURGICAL DELAY OF TWO-THREE (2-3) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753819 ↗
• MalfunctionJan 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOUR (4) 4.3 PERCUTANEOUS THREADED DRILL GUIDES WERE FREELY SPINNING ON THE TWO (2) BROWN HANDLES. THE SPINNING DRILL GUIDES WOULD NOT LOCK INTO THE PLATE THROUGH THE AIMING ARM. THE THREADED GUIDES WERE NOT LOCKING INTO THE HANDLES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO REPORTED PATIENT CONSEQUENCE. CONCOMITANT DEVICE: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). AIMING ARM (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). 4.3MM PERCUTANEOUS THREADED DRILL GUIDE (PART NUMBER 324.203, LOT UNKNOWN, QUANTITY 3). HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES (PART NUMBER 03.120.022, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147952 ↗
• MalfunctionJan 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOUR (4) 4.3 PERCUTANEOUS THREADED DRILL GUIDES WERE FREELY SPINNING ON THE TWO (2) BROWN HANDLES. THE SPINNING DRILL GUIDES WOULD NOT LOCK INTO THE PLATE THROUGH THE AIMING ARM. THE THREADED GUIDES WERE NOT LOCKING INTO THE HANDLES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO REPORTED PATIENT CONSEQUENCE. CONCOMITANT DEVICE: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); AIMING ARM (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); 4.3MM PERCUTANEOUS THREADED DRILL GUIDE (PART NUMBER 324.203, LOT UNKNOWN, QUANTITY 3); HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES (PART NUMBER 03.120.022, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147897 ↗
• MalfunctionJan 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4 4.3 PERCUTANEOUS THREADED DRILL GUIDES WERE FREELY SPINNING ON THE 2 BROWN HANDLES. THE SPINNING DRILL GUIDES WOULD NOT LOCK INTO THE PLATE THROUGH THE AIMING ARM. THE THREADED GUIDES WERE NOT LOCKING INTO THE HANDLES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO REPORTED PATIENT CONSEQUENCE. CONCOMITANT DEVICE: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). AIMING ARM (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). 4.3MM PERCUTANEOUS THREADED DRILL GUIDE (PART NUMBER 324.203, LOT UNKNOWN, QUANTITY 3). HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES (PART NUMBER 03.120.022, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES 1 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147815 ↗
• MalfunctionJan 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOUR (4) 4.3 PERCUTANEOUS THREADED DRILL GUIDES WERE FREELY SPINNING ON THE 2 BROWN HANDLES. THE SPINNING DRILL GUIDES WOULD NOT LOCK INTO THE PLATE THROUGH THE AIMING ARM. THE THREADED GUIDES WERE NOT LOCKING INTO THE HANDLES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO REPORTED PATIENT CONSEQUENCE. CONCOMITANT DEVICE: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). AIMING ARM (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). 4.3MM PERCUTANEOUS THREADED DRILL GUIDE (PART NUMBER 324.203, LOT UNKNOWN, QUANTITY 3). HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES (PART NUMBER 03.120.022, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES 1 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147380 ↗
• MalfunctionJan 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.5MM WIRE GUIDES AND 4.3MM DRILL GUIDES FOR OUR 4.5MM VA CURVED CONDYLAR SETS WERE MADE INCORRECTLY. THE HEXAGONAL KEY COULD NOT FIT INTO THE SMALL HOLES IN THE SLEEVES. THERE ARE FOUR (4) OF EACH SLEEVE FOR A TOTAL OF EIGHT (8). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8267436 ↗