NA 313.843Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10887587036885), received between Nov 6, 2018 and Dec 12, 2025 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (19 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED: DAMAGE MEANING THE RED PLASTIC KNOBS IN THE CORNERS OF THE TRAY AND PLASTIC PEGS THAT KEEP INSTRUMENTS SEPARATED HAVE BROKEN OFF SO INSTRUMENTS SHUFFLE AROUND DURING STERILIZATION AND CAN FALL OUT WHEN OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791257 ↗
• MalfunctionDec 12, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED: DAMAGE MEANING THE RED PLASTIC KNOBS IN THE CORNERS OF THE TRAY AND PLASTIC PEGS THAT KEEP INSTRUMENTS SEPARATED HAVE BROKEN OFF SO INSTRUMENTS SHUFFLE AROUND DURING STERILIZATION AND CAN FALL OUT WHEN OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791041 ↗
• MalfunctionAug 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON MENTIONED THAT DURING A FOOT SURGERY, THE THREADED LOCKING GUIDES WERE NOT ENGAGING IN THE PLATE AND THE HEAD OF THE SCREWDRIVER WAS NOT FULLY ENGAGING THE SCREW. USED THE OTHER SCREW DRIVER IN THE SET. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826876 ↗
• MalfunctionJul 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T6 SCREWDRIVER SHAFT ARE NO LONGER RETAINING THE SCREWS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459698 ↗
• MalfunctionJul 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T6 SCREWDRIVER SHAFT ARE NO LONGER RETAINING THE SCREWS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459675 ↗
• MalfunctionJul 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T6 SCREWDRIVER SHAFT ARE NO LONGER RETAINING THE SCREWS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459657 ↗
• MalfunctionJul 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T6 SCREWDRIVER SHAFT ARE NO LONGER RETAINING THE SCREWS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459641 ↗
• MalfunctionJan 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JAN 7, 2025 THE DRIVER SHAFTS WILL NOT ENGAGE WITH QUICK CONNECT HANDLE. IT WAS FOUND POST-OP. THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170263 ↗
• MalfunctionJan 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JAN 7, 2025 THE DRIVER SHAFTS WILL NOT ENGAGE WITH QUICK CONNECT HANDLE. IT WAS FOUND POST-OP. THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170250 ↗
• MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVER HANDLE AND T6 DRIVER DID NOT ATTACH TOGETHER FOR SOME REASON. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT SD6/SELF-RETAINING/2.0MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20051552 ↗
• MalfunctionJul 24, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, THE SCREWDRIVER NO LONGER RETAINS THE SCREW BECAUSE IT IS DULL. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT SD6/SELF-RETAINING/2.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817685 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, THE END OF THE DRIVER DID NOT RETAIN SCREWS BECAUSE IT WAS DULL. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT SD6/SELF-RETAINING/2.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805665 ↗
• MalfunctionMay 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SCREWDRIVERS ARE STRIPPED AND DRILL GUIDES ARE BROKEN. THIS REPORT IS FOR ONE (1)SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962158 ↗
• MalfunctionMay 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SCREWDRIVERS ARE STRIPPED AND DRILL GUIDES ARE BROKEN. IT WAS UNKNOWN IF THERE WERE PATIENT INVOLVEMENT, OR PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TEN (10) DEVICES. (B)(4) AND (B)(4) ARE RELATED TO CAPTURE ADDITIONAL IPS. (B)(4) INCLUDES DRIVE SCREWDRIVER SHAFT T8 105MM (314.467) X1 SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 (313.843) X1 2.7MM/2.0MM DOUBLE DRILL SLEEVE (312.24) X2 2.4MM/1.8MM DOUBLE DRILL SLEEVE (312.18) X2 2.0MM/1.5MM DOUBLE DRILL SLEEVE (312.22) X2 2.7MM UNIVERSAL DRILL GUIDE (23.26) X3 2.4MM UNIVERSAL DRILL GUIDE (323.202) X3 2.0MM UNIVERSAL DRILL GUIDE (323.201) X3 (B)(4) INCLUDES SDDRIVE SCREWDRIVER SHAFT T8 105MM (314.467) X2 SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 (313.843) X2 THIS REPORT IS FOR ONE (1) SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955773 ↗
• MalfunctionMay 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SCREWDRIVERS ARE STRIPPED AND DRILL GUIDES ARE BROKEN. THIS REPORT IS FOR ONE (1) SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955578 ↗
• MalfunctionFeb 28, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP DEPTH GAUGE DIDN'T SLIDE SMOOTHLY AND THET6 STAR-DRIVER WAS STRIPPED, THE 2.0 LOCKING TOWERS WOULDN'T LOCK INTO PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT 2 LONG SELF-HOLDING THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454906 ↗
• MalfunctionJan 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON JANUARY 10, 2023, POST OPERATION, IT WAS FOUND THAT SCREWDRIVER RECESS WAS STRIPPED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16259079 ↗
• MalfunctionJan 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, POST OPERATION, IT WAS FOUND THAT SCREWDRIVER RECESS WAS STRIPPED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16259060 ↗
• MalfunctionOct 17, 2022Break; Break

  IT WAS REPORTED THAT ON(B)(6)2022 SEVERAL INSTRUMENTS WERE BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR ONE (1)SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 THIS IS REPORT 6 OF 7 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619996 ↗
• MalfunctionOct 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER SHAFT AND SCREWDRIVER HANDLE WERE NOT CONNECTING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER SHAFT SD6/SELF-RETAINING/2.0MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527697 ↗
• InjuryMar 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE PUTTING A 2.0 SCREW CORTEX IN, THE SCREW HEAD STRIPPED OUT. THE SCREW HAD TO BE REMOVED WITH PLIERS, BUT IT WAS SUCCESSFULLY REMOVED. ADDITIONALLY, A SCREW DRIVER SHAFT WAS BENT. THERE WERE 5 MINUTES SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905579 ↗
• MalfunctionOct 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER T15 TIP WAS STRIPPED, THE SCREWDRIVER SELF RETAINING TIP WAS STRIPPED, THE INSERTER FOR ELASTIC NAIL PLASTIC PIECE ON THE HANDLE WAS CRACKED AND BROKEN, THE SCREWDRIVER T8 METAL CAP WILL NO LONGER STAY IN THE WOODEN HANDLE AND THE DRIVE SHAFT FOR REAMER IRRIGATOR ASPIRATOR (RIA) 2 WAS BENT. THE ISSUE WAS DISCOVERED WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT SD6/SELF-RETAINING/2.0MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712207 ↗
• MalfunctionJul 22, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 WERE CHIPPED AND NOT ATTACHING TO SCREWS. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT SD6. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214634 ↗
• MalfunctionJul 22, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0 WERE CHIPPED AND NOT ATTACHING TO SCREWS. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT SD6. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214594 ↗
• MalfunctionJan 29, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS DISCOVERED THAT SOME INSTRUMENTS WERE DAMAGED. THE STAR DRIVE SCREWDRIVER SHAFT IS BENT AND WOBBLES IN THE SCREWDRIVER HANDLE, WIRE GUIDE SLEEVE WON'T FULLY INSERT INTO THE BLADE GUIDE, BLADE/SCREW GUIDE SLEEVE WILL NOT LET THE BLADE INSERTER ENGAGE THE RIFLING PROPERLY, TUBE PART OF DEPTH GAUGE FOR SCREWS IS BENT AND WILL NOT LET THE SCREW DOWN PIECE ENGAGE THE THREADS, THE INSERTION GUIDE WAS BENT AND THE SLEEVES WERE UNABLE TO BE INSERTED FULL. HOWEVER, IT WAS SET ASIDE AND INADVERTENTLY PLACED IN THE SHARPS CONTAINER BY THE STAFF AND WAS UNABLE TO BE RETRIEVED. THERE WAS NO PATIENT INVOLVEMENT WITH ANY OF THESE ITEMS. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. CONCOMITANT PRODUCTS: DEPTH GAUGE FOR SCREWS Ø 2.7 TO 4.0 MM, MEASURING RANGE UP TO 60 MM, 3.2MM WIRE GUIDE SLEEVE. BLADE/SCREW GUIDE SLEEVE. DEPTH GAUGE FOR SCREWS Ø 2.7 TO 4.0 MM, INSERTION GUIDE. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT SD6/SELF-RETAINING/2.0MM. THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252005 ↗