NA 03.114.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886982073037), received between May 2, 2017 and Apr 6, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVERS ARE WORN OUT. THEY DO NOT ENGAGE SCREW HEADS PROPERLY ANYMORE. THE SURGERY WAS DELAYED 2 MINUTES DUE TO THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794273 ↗
• MalfunctionOct 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS A STRIPPED T4 SCREW DRIVER 1.5 LCP MODULE, THAT NEEDS TO BE REPLACED. THIS WAS PRIOR TO THE PATIENT COMING INTO THE ROOM SO NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378515 ↗
• MalfunctionApr 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, VA HAND TISSUE PROTECTOR WAS TOO BENT TO WORK, AND SCREWDRIVER HEAD WAS STRIPPED. NO PATIENT WAS HARMED BUT WE DISPOSED THE PIECES. SALES REP NEED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885261 ↗
• MalfunctionFeb 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ALL DRIVERS STRIPPED- CAUSING ISSUES. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER SFT HOLDING SLEEVE/T4/66. THIS IS REPORT 6 OF 6 FOR COMPLAINT PC-(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18751422 ↗
• MalfunctionFeb 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ALL DRIVERS STRIPPED- CAUSING ISSUES. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER SFT HOLDING SLEEVE/T4/66. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18751395 ↗
• MalfunctionFeb 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ALL DRIVERS STRIPPED- CAUSING ISSUES. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER SFT HOLDING SLEEVE/T4/66. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18751368 ↗
• MalfunctionFeb 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ALL DRIVERS STRIPPED- CAUSING ISSUES. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER SFT HOLDING SLEEVE/T4/66. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18751350 ↗
• MalfunctionFeb 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ALL DRIVERS STRIPPED- CAUSING ISSUES. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER SFT HOLDING SLEEVE/T4/66 THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18751319 ↗
• MalfunctionFeb 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ALL DRIVERS STRIPPED- CAUSING ISSUES. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER SFT HOLDING SLEEVE/T4/66. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18751311 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DEVICES IN QUESTION BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058905 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DEVICES IN QUESTION BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058900 ↗
• MalfunctionDec 16, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE THREADS OF THE SCREWDRIVER SHAFT WITH HOLDING SLEEVE WERE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998835 ↗
• MalfunctionAug 16, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE SCREWDRIVERS ARE STRIPPED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1)SD SCREWDRIVER SFT HOLDING SLEEVE/T4/66. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234305 ↗
• MalfunctionDec 7, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE STARDRIVE SCREWDRIVER SHAFT WITH HOLDING SLEEVE WAS DULL AND HAS STOPPED RETAINING SCREW DRIVE RECESS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956274 ↗
• MalfunctionNov 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A WRIST SURGERY ON (B)(6) 2021, TWO (2) SCREWDRIVER SHAFTS WERE NOT RETAINING SCREW PROPERLY. THEY WERE UNABLE TO ASSEMBLE PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728587 ↗
• MalfunctionNov 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A WRIST SURGERY ON (B)(6) 2021, TWO (2) SCREWDRIVER SHAFTS WERE NOT RETAINING SCREW PROPERLY. THEY WERE UNABLE TO ASSEMBLE PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728576 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER'S SET ON AN UNKNOWN DATE, A STAR DRIVE SCREWDRIVER SHAFT WITH HOLDING SLEEVE WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A STAR DRIVE SCREWDRIVER SHAFT WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9075763 ↗
• MalfunctionJul 12, 2018Naturally Worn; Naturally Worn

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN IMPLANT PLACEMENT PROCEDURE ON (B)(6) 2018, THE HEADS OF TWO TITANIUM (TI) CORTEX SCREWS BROKE DUE TO THE WORN TIP OF TWO (2) STARDRIVE SCREWDRIVER SHAFTS. ALL DEVICE FRAGMENTS WERE EASILY REMOVED AND NEW SCREWS WERE IMPLANTED TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPORTED DELAY OF FORTY FIVE (45) MINUTES. THERE IS NO OTHER REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7681231 ↗
• MalfunctionDec 7, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORT THAT ON (B)(6) 2017, PATIENT UNDERWENT IMPLANT SURGERY FOR TREATMENT OF A (ORIF) OPEN REDUCTION INTERNAL FIXATION TO THE RIGHT FOURTH METACARPAL BONE DUE TO A BONE FRACTURE WHERE THE SURGEON WAS USING THE 1.5 MM (LCP)LOCKING COMPRESSION SYSTEM. DURING THE PRODUCE, SURGEON CHOSE TO USE ONE (1) 1.5 MM LCP T-PLATE AND THREE (3) 1.5 MM CORTEX SELF TAPPING SCREWS. SURGEON ORIGINALLY WANTED TO USE A CONDYLAR PLATE FOR THE FRACTURE REDUCTION, BUT THIS PLATE WAS UNAVAILABLE IN THE LCP SET. (DUE TO THIS PLATE WAS USED DURING A SURGERY THE DAY BEFORE.) SURGEON CUT AND CONTOURED THE T-PLATE TO THE APPROPRIATE LENGTH AND ATTEMPTED TO INSERT THREE (3) CORTEX SCREWS. SURGEON STRUGGLED WITH THREE (3) DIFFERENT SCREWDRIVERS WHEN ATTEMPTING TO IMPLANT EACH OF THE THREE (3) CORTEX SCREWS. ALL THREE SCREWDRIVERS BECAME STRIPPED AND WOULD NO LONGER RETAIN THE SCREWS. ADDITIONAL SCREWDRIVERS WERE AVAILABLE IN THE OPERATING ROOM TO CONTINUE THE SURGERY. AT THIS POINT IN THE PROCEDURE, SURGEON REMOVED THE PREVIOUSLY IMPLANTED THREE CORTEX SCREWS AND PLATE. PATIENT WAS ULTIMATELY IMPLANTED WITH TWO (2) 1.5 MM CORTEX SCREWS AND FIBER WIRE SUTURES TO COMPRESS THE BONE FRACTURE. SURGERY WAS COM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7096537 ↗
• MalfunctionSep 22, 2017Material Deformation; Material Deformation

  FURTHER IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT, AND THE PATIENT OUTCOME WAS REPORTED TO BE GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6887520 ↗
• MalfunctionJul 28, 2017Dull, Blunt; Device Operates Differently Than Expected; Material Twisted/Bent; Dull, Blunt; Device Operates Differently Than Expected; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A SCREWDRIVER WHICH REPORTEDLY WAS DAMAGED. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE DISTAL STRA DRIVE TIP WAS TWISTED AND STRIPPED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6751795 ↗
• MalfunctionJun 9, 2017Dull, Blunt; Dull, Blunt

  WHEN THE DEVICE WAS RECEIVED BY THE MANUFACTURER, IT WAS NOTED THAT THE DISTAL STARDRIVE TIP OF THE DEVICE WAS TWISTED AND STRIPPED.

  Patient problems: No Patient Involvement

  MAUDE report 6629527 ↗
• MalfunctionJun 9, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A SCREWDRIVER THAT WAS REPORTEDLY STRIPPED. THIS IS REPORT 2 OF 20 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6629419 ↗
• MalfunctionJun 9, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A SCREWDRIVER THAT WAS REPORTEDLY STRIPPED. THIS IS REPORT 1 OF 20 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6629366 ↗
• MalfunctionMay 2, 2017Dull, Blunt; Dull, Blunt

  IT IS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2017, THE STARDRIVE SCREWDRIVER SHAFT WITH HOLDING SLEEVE APPEARED TO BE STRIPPED AS IT WOULD NOT RETAIN THE SCREW DURING FINAL TIGHTENING. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF APPROXIMATELY TEN (10) MINUTES. PRELIMINARY INSPECTION OF THE RETURNED DEVICE REVEALED THE TIP WAS SLIGHTLY DISTORTED AND THE RED COLORED COATING TOWARD THE PROXIMAL END OF THE STARDRIVE WAS STRIPPED. CONCOMITANT MEDICAL PRODUCTS: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6539110 ↗