NA 399.68Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982203038), received between Feb 2, 2018 and Feb 3, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT THE DEVICE HAS BROKEN TIP, WITH THE CORNER OF THE GOUGE BUSTED OFF. IT WAS DISCOVERED BY MDR DURING REPROCESSING OF THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250895 ↗
• MalfunctionOct 10, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, TWO INSTRUMENTS WERE DISCOVERED TO BE BROKEN. 311.44 WAS FOUND WITH THE BEARINGS BROKEN IN THE LATCH PORTION OF THE T HANDLE. 399.680 WAS FOUND WITH A BROKEN TIP. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) GOUGE W/10 L205/90. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906550 ↗
• MalfunctionApr 13, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WOOD HANDLED INSTRUMENTS ARE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEEL-PACKED AND STERILIZED. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR ONE (1) GOUGE W/10 L205/90. THIS IS REPORT 7 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738472 ↗
• MalfunctionSep 9, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING CLEANING IT WAS DISCOVERED THAT THE GOUGE FOR BROKEN SCREW EXPOSURE CRACKED IN HANDLE. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE HANDLE OF THE SCREW GOUGE WAS CHIPPED AND BROKEN ON THE DISTAL AND PROXIMAL ENDS. THE CHIPPED/BROKEN FRAGMENTS WERE NOT RETURNED. THIS REPORT IS FOR ONE (1) HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451144 ↗
• MalfunctionApr 19, 2021Break; Break

  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) HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE. THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686808 ↗
• MalfunctionApr 19, 2021Break; Break

  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) HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE. THIS IS REPORT 8 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686793 ↗
• MalfunctionApr 19, 2021Break; Break

  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) HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE. THIS IS REPORT 3 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686668 ↗
• InjuryFeb 2, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A HARDWARE REMOVAL/REVISION PROCEDURE FOR TOTAL KNEE ARTHROPLASTY (RETROGRADE NAIL WITH 4 INTERLOCKING SCREWS AND ENDCAP). UPON LOCATING THE HARDWARE, IT WAS DISCOVERED THAT ALL OF THE SCREW HEAD RECESS WERE STRIPPED AND SCREWDRIVERS WERE UNSUCCESSFUL FOR REMOVAL. OSTEOTOMES, CURETTES, AND GOUGES WERE USED TO LOOSEN BONE GROWTH AROUND HARDWARE AND A LOCKING PLIER AND VICE GRIP WERE USED TO REMOVE THREE (3) OF THE SCREWS. DURING THIS PROCESS, A SYNTHES GOUGE BROKE AND PORTION OF THE DEVICE MAY HAVE BEEN RETAINED IN THE PATIENT. INTRA-OPERATIVE RADIOGRAPHY WAS UNABLE TO DETERMINE LOCATION OF THE PIECE. SECONDARILY, THE MOST DISTAL SCREW WAS UNABLE TO BE REMOVED AND THE SURGEON DECIDE TO ABORT THE PLANED PROCEDURE. THE REMAINDER OF THE HARDWARE WHICH INCLUDES THE RETROGRADE NAIL AND MOST DISTAL INTERLOCKING SCREW WERE REMOVED WITHOUT INCIDENT DURING ANOTHER PROCEDURE AND ANOTHER FACILITY. THIS COMPLAINT CAPTURES INTRA-OPERATIVE BREAKAGE OF GAUGE. PC- 000110817 CAPTURES THE REMOVAL OF HARDWARE (THREE SCREWS). CONCOMITANT DEVICES REPORTED: RETROGRADE NAIL (PART#: UNKNOWN, LOT #: UNKNOWN, QTY: 1) INTERLOCKING SCREWS (PART #: UNKNOWN,

  Patient problems: Foreign Body In Patient

  MAUDE report 7236983 ↗