NA 393.103Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10886982199010), received between Dec 30, 2020 and Sep 10, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (23 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713038 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  It was reported that there was wear and tear on the instruments and they needed to be replaced. There was no reported patient harm with no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713018 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713002 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713001 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  It was reported that there was wear and tear on the instruments and they needed to be replaced. There was no reported patient harm with no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713000 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  It was reported that there was wear and tear on the instruments and they needed to be replaced. There was no reported patient harm with no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50712993 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  It was reported that there was wear and tear on the instruments and they needed to be replaced. There was no reported patient harm with no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50712987 ↗
• MalfunctionSep 2, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576200 ↗
• MalfunctionMar 10, 2026Material Deformation

  IT WAS REPORTED THAT IT WAS IDENTIFIED THAT THE DEVICE HAS STRIPPED DRILL CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559380 ↗
• MalfunctionFeb 26, 2026Nonstandard Device; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE ISSUES WITH THE INSTRUMENTS OCCURRED INTRAOPERATIVELY DURING SETUP OF THE INSTRUMENT TRAY WITH THE SCRUB NURSE. ADAPT F/SELDRILL SCHANZ SCR Ø5 THERE IS DAMAGE TO THE COUPLING INTERFACE WHERE THE INSTRUMENT CONNECTS TO THE AO DRILL ATTACHMENT. THE ATTACHED IMAGE SHOWS A SLIGHT DEFORMATION ON THE COUPLING SIDE. THERE APPEARS TO BE METAL DEBRIS CREATING A RAISED AREA, PREVENTING THE AO DRILL ATTACHMENT FROM FULLY SEATING AND ENGAGING. THE SCRUB NURSE ATTEMPTED TO CONNECT THE ATTACHMENT INTRAOPERATIVELY AND WAS UNABLE TO DO SO. I ALSO ATTEMPTED TO ENGAGE IT POST-OPERATIVELY WITH THE SAME RESULT. THE PROCEDURE PROCEEDED; HOWEVER, THIS REDUCED EFFICIENCY. THE TEAM WAS REQUIRED TO MANUALLY CHUCK THE SCHANZ PINS, AND THE SURGEONS USED A CHUCK KEY FOR REMOVAL, ADDING ADDITIONAL STEPS TO THE WORKFLOW. DOUBLEJOINT CPL F/LARGE-DISTRACT THIS ITEM IS LISTED AS COMPRISING FOUR COMPONENTS. THE METAL PIN THAT INSERTS INTO THE ROD HOLE WAS NOT PRESENT IN THE TRAY. IN THE SURGICAL TECHNIQUE GUIDE FOR THE LARGE FEMORAL DISTRACTOR, THIS COMPONENT IS IDENTIFIED AS THE "COTTER PIN". THE PROCEDURE WAS ABLE TO BE COMPLETED. HOWEVER, THE TRAY WAS INCOMPLETE AND THE COMPONENT WAS UNAVAILA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461782 ↗
• MalfunctionNov 13, 2025Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL 5.0 PIN ADAPTERS WERE GETTING JAMMED ON EXFIX SHANZ PINS. DEVICES APPEARED TO BE STRIPPING OUT INSIDE. EVENT WAS NOTICED IN STERILE PROCESSING WHILE PUTTING TOGETHER TRAYS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546978 ↗
• MalfunctionNov 13, 2025Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL 5.0 PIN ADAPTERS WERE GETTING JAMMED ON EXFIX SHANZ PINS. DEVICES APPEARED TO BE STRIPPING OUT INSIDE. EVENT WAS NOTICED IN STERILE PROCESSING WHILE PUTTING TOGETHER TRAYS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546968 ↗
• MalfunctionNov 13, 2025Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL 5.0 PIN ADAPTERS WERE GETTING JAMMED ON EXFIX SHANZ PINS. DEVICES APPEARED TO BE STRIPPING OUT INSIDE. EVENT WAS NOTICED IN STERILE PROCESSING WHILE PUTTING TOGETHER TRAYS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546967 ↗
• MalfunctionNov 13, 2025Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL 5.0 PIN ADAPTERS WERE GETTING JAMMED ON EXFIX SHANZ PINS. DEVICES APPEARED TO BE STRIPPING OUT INSIDE. EVENT WAS NOTICED IN STERILE PROCESSING WHILE PUTTING TOGETHER TRAYS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546965 ↗
• MalfunctionNov 13, 2025Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL 5.0 PIN ADAPTERS WERE GETTING JAMMED ON EXFIX SHANZ PINS. DEVICES APPEARED TO BE STRIPPING OUT INSIDE. EVENT WAS NOTICED IN STERILE PROCESSING WHILE PUTTING TOGETHER TRAYS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546961 ↗
• MalfunctionNov 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THEY NOTICED THAT THE PART WAS NOT CONNECTING TO ANY INSTRUMENT AND DOES NOT HOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480300 ↗
• MalfunctionNov 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SCREWDRIVERS ARE WARPED, AND THE LETTERS ON MEASURING STICK ARE FADED. THE RATCHETING DRIVERS HAVE SCREWDRIVERS STUCK ON THEM. ALSO, THE 5.0 SCHANTZ ADAPTER QC ENDS ARE CHEWED UP. ADVERSE EVENT OR PATIENT CONSEQUENCES ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20659502 ↗
• MalfunctionNov 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SCREWDRIVERS ARE WARPED, AND THE LETTERS ON MEASURING STICK ARE FADED. THE RATCHETING DRIVERS HAVE SCREWDRIVERS STUCK ON THEM. ALSO, THE 5.0 SCHANTZ ADAPTER QC ENDS ARE CHEWED UP. ADVERSE EVENT OR PATIENT CONSEQUENCES ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658864 ↗
• MalfunctionOct 23, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE SALES REPRESENTATIVE NOTICED THAT SEVERAL WERE DAMAGED. IT IS UNKNOWN WHEN THE INSTRUMENTS WERE DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE AFFECTED PRODUCTS ARE: 1. DISTRACTOR: THERE IS A SPRING TECH DEVICE IN THE HANDLE, AND THAT SPRING DEVICE IS BROKEN. 2. DEPTH GAUGE: BENT AND UNABLE TO BE USED. 3. POWER ADAPTER FOR SCHANTZ PINS: STRIPPED AND UNABLE TO HOLD THE PIN IN IT. 4. TENSION HOLDER FOR THE CABLE SET (3X): WILL NOT HOLD THE ATTACHMENT BIT FOR THE TENSION HOLDER ANY LONGER. 5.ATTACHMENT BIT (3X): THE TIPS OF THESE WERE BENT IN; THE CABLE WAS UNABLE TO GO THROUGH IT. 6. HANDLE QUICK COUPLING (2X): THE RUBBER ON THE HANDLE WAS CUT AND NOT ALLOWING THE HANDLE TO BE CLEANED PROPERLY. 7. T25 SCREWDRIVER (2X): THE TIP WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513882 ↗
• MalfunctionSep 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE PUTTING ON A SYNTHES LG EXTERNAL FIXATOR. THE SURGEON WAS USING A SELF DRILLING SCHANZ SCREW CATALOG #294.786 ON THE TIBIA. THE SCHANZ SCREW WAS BEING INSERTED USING THE POWER ADAPTOR 393.103 FROM THE LG EX-FIX TRAY. THE SURGEON HAD PREDRILLED THE HOLE WITH A3.5 DRILL. THE PIN HIT THE FAR CORTEX AND STOPPED THE DRILL. THE PIN BECAME STUCK IN THE POWER ADAPTOR AND COULD NOT BE REMOVED. WE HAD TO CUT THE PIN WITH THE ADAPTOR IN ORDER TO CONTINUE WITH THE CASE. THERE WAS A 30 MINUTES OF SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20171649 ↗
• MalfunctionMay 15, 2024Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RUST WAS INSPECTED ON DEVICES POST OPERATIVELY DUE TO WEAR. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325750 ↗
• MalfunctionMay 15, 2024Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RUST WAS INSPECTED ON DEVICES POST OPERATIVELY DUE TO WEAR. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325643 ↗
• MalfunctionMay 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUSTOMER COULD NOT REMOVE THE DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS FROM THE AO QUICK COUPLING. THIS REPORT IS FOR ONE (1) DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19241961 ↗
• MalfunctionJan 2, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT SEVERAL INSTRUMENTS WERE DAMAGED. THE HANDLE WITH QUICK COUPLING, SMALL WAS WORN. THE PLASTIC ON THE HANDLE WAS CRACKED. THE DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS IS A QUICK CONNECT FOR SHANZ PINS. WHERE THE QUICK CONNECT GOES INTO THE DRILL, IT IS WORN AND UNABLE TO GO INTO THE DRILL. THE 5.0MM FLEXIBLE SHAFT WAS WORN. THE TIP OF THE REAMER SHAFT HAS PRONGS ON IT, AND THE PRONGS WERE BENT AND UNABLE TO HOLD THE REAMER HEAD IN PLACE. ANOTHER 5.0MM FLEXIBLE SHAFT WAS DAMAGED. THE 5.0MM FLEXIBLE SHAFT 620MM WAS WORN. IT WAS A LONG REAR SHAFT, AND THE TIP OF THE REAMERS SHAFT HAS PRONGS ON IT, AND THE PRONGS WERE BENT AND UNABLE TO HOLD THE REAMER HEAD IN PLACE. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED TO THESE ITEMS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427723 ↗
• MalfunctionSep 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO DEVICES WERE STUCK. THE TWO PIECES FUSED TOGETHER. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. THIS REPORT IS FOR ONE (1) DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17844915 ↗