NA 03.114.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982072993), received between Dec 7, 2017 and Feb 7, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Break; Break

  DURING THE SURGERY, WHEN THE SPECIALIST WAS REMOVING THE THIRD (3) SCREW, THE TIP OF THE SCREWDRIVER PIECE BROKE. A QUICK SOLUTION WAS GIVEN BY REMOVING THE FRAGMENTS OF THIS PIECE THAT BROKE AND ANOTHER SCREWDRIVER PIECE WAS GIVEN TO THE DOCTOR, BUT THIS ALSO BROKE AT THE MOMENT WHEN HE WAS REMOVING THE FOURTH (4) AND LAST SCREW. DUE TO THIS NOVELTY, THERE WAS NO DISCOMFORT IN THE SPECIALIST SINCE ALL THE SCREWS WERE REMOVED WITH THESE SCREWDRIVER PIECES. THE SURGERY WAS SUCCESSFULLY COMPLETED, WITHOUT ALTERATIONS IN THE SURGICAL TIMES AND WITHOUT AFFECTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334344 ↗
• MalfunctionMay 16, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON APRIL 21, 2024 THE THREADS ON THE SCREW SHAFT WERE BENT AND WORN WHEN AT THE OFFICE LOOKING FOR SCREW REMOVAL PARTS FOR A LCP MINI FRAG CASE. THERE WAS NO PATIENT OUTCOME REPORTED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336896 ↗
• MalfunctionJan 19, 2024Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, WHILE THE SPECIALIST WAS TIGHTENING A SCREW, THE TIP OF THE SCREWDRIVER SHAFT IN QUESTION SPLIT. THERE WAS NO ADVERSE PATIENT IMPACT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING A REPLACEMENT SCREWDRIVER SHAFT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545596 ↗
• MalfunctionSep 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER BROKE DURING THE PROCEDURE, AND THE TOOTHED SCREWDRIVER PASSED, BUT THE TIP WAS SLIGHTLY WORN. IT DID NOT AFFECT THE PATIENT BECAUSE IT WAS ALREADY FINISHED. THIS REPORT IS FOR ONE (1)SD SCREWDRIVER SFT T4/42/SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17808181 ↗
• MalfunctionSep 14, 2023Break; Break

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: VETERINARY COMPLAINT: IT WAS REPORTED THAT ON (B)(6), 2023, THE SCREWDRIVER SHAFT BROKE WHEN FIRST USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744391 ↗
• MalfunctionApr 7, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, SMALL DRIVER DID NOT STAY IN CHUCK, LARGER OF THE TWO DRIVER'S THREADS WERE TORQUED AND TWISTED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER SFT T4/42/SELF-RETAINING THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704274 ↗
• MalfunctionFeb 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER PIECES IN QUESTION WOULD NOT HOLD THE SCREWS. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379439 ↗
• MalfunctionAug 4, 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 SCREWDRIVER SHAFT IN QUESTION WOULD NOT GRAB SCREWS. THE ISSUE DELAYED SURGERY FOR APPROXIMATELY 15 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE IMPACT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163399 ↗
• MalfunctionMar 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WENT AN UNKNOWN SURGERY WITH THE SCREWDRIVER SHAFT. THE TIP OF SCREWDRIVER SHAFT WAS WORN, SO THAT THE HEAD OF THE LOCKING SCREW GOT STRIPPED WHILE LOCKING. THE SCREWDRIVER SHAFT WAS PURCHASED ON (B)(6) 2022, AND IT HAS BEEN USED FOR ONLY TWICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE SD SCREWDRIVER SFT T4/42/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636540 ↗
• MalfunctionApr 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, TWO (2) 1.1MM DRILL BITS AND ONE (1) 1.0MM DRILL BIT WERE BENT AND WERE UNABLE TO CUT. ONE (1) SCREWDRIVER WAS UNABLE TO HOLD THE SCREWS. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674853 ↗
• MalfunctionOct 14, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 WHEN ADJUSTING OR TIGHTENING THE SCREW, THE SCREWDRIVER PART BROKE. CONCOMITANT DEVICE: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10678630 ↗
• MalfunctionMay 20, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A 5TH METACARPAL OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE SPLINES OF THE 3 STARDRIVE SCREWDRIVER SHAFT SELF-RETAINING WERE TWISTED AND NOT PROPERLY GRASPING THE SCREW HEAD. THERE WAS NO BACK UP AVAILABLE. THE DRIVERS FUNCTIONED HOWEVER NOT PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ISSUES AND WITH NO SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10077354 ↗
• MalfunctionJan 28, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE STARDRIVE SCREWDRIVER SHAFT T4 AND STARDRIVE SCREWDRIVER SHAFT T4, SELF-RETAINING ARE NOT EFFECTIVELY DRIVING THE SCREWS IN. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282823 ↗
• 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 T4/42MM/SELF-RETAINING. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7681196 ↗
• 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 7096174 ↗
• 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 7095872 ↗