NA 03.130.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982075208), received between Jan 29, 2019 and Aug 25, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437683 ↗
• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437669 ↗
• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437633 ↗
• MalfunctionMar 5, 2026Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS WARPED AND WILL NO LONGER HOLD A SCREW IN ON THE TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523868 ↗
• MalfunctionNov 25, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED, THAT ON NOVEMBER 14, 2024. THE SCREWDRIVER TIP WAS WARPED, PREVENTING PROPER INSERTION OF SCREWS. THERE WAS NO PATIENT INVOLVEMENT. ISSUE WAS NOTED, POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775203 ↗
• MalfunctionDec 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING POSTOPERATIVE INSPECTION OF THE SET, IT WAS NOTED THAT THE T6 SCREWDRIVER SHAFT WAS STUCK IN THE SCREWDRIVER HANDLE. THE DEVICE HAS BEEN THROUGH STERILE PROCESSING, BUT IT CANNOT BE COMPLETELY STERILIZED PER HOSPITAL STANDARDS BECAUSE THE SCREWDRIVER SHAFT IS STUCK IN THE HANDLE. THE LATCH MECHANISM ON THE SCREWDRIVER HANDLE IS STUCK AND IS NOT ALLOWING THE SCREWDRIVER SHAFT TO DISCONNECT WITH THE HANDLE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR SD SCRWDRVR SHFT/T6 50/SELF-RETAIN/HXC FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419130 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE T-6 SCREWDRIVER TIP BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH UNKNOWN SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SD SCRWDRVR SHFT/T6 50/SELF-RETAIN/HXC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814377 ↗
• MalfunctionOct 11, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, TWO SCREWDRIVER SHAFTS FOR THE VARIABLE ANGLE (VA) HAND SYSTEM WERE NOT RETAINING/HOLDING SCREWS VERY WELL; THEY ARE SHOWING SIGNS OF WEAR. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A STARDRIVE SCRWDRVR SHFT/T6 50MM/SELF-RETAINING/HXC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583565 ↗
• MalfunctionOct 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE RECESS OF THE T6 SCREWDRIVER BLADE FROM THE VA LOCKING HAND SET WASN'T PROPERLY HOLDING THE 2.0MM CORTEX SCREWS. CONCOMITANT DEVICE: UNK - SCREWS: TRAUMA(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCRWDRVR SHFT/T6 50MM/SELF-RETAINING/HXC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12640700 ↗
• MalfunctionOct 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE RECESS OF THE T6 SCREWDRIVER BLADE FROM THE VA LOCKING HAND SET WASN'T PROPERLY HOLDING THE 2.0MM CORTEX SCREWS. CONCOMITANT DEVICE: UNK: SCREWS: TRAUMA(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCRWDRVR SHFT/T6 50MM/SELF-RETAINING/HXC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12640548 ↗
• MalfunctionDec 3, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREWDRIVERS FROM A SET WERE FOUND WORN OUT. THE SET HAS BEEN IN COMMISSION FOR TWO MONTHS. THE REPORTING FACILITY REQUESTED FOR A REPLACEMENT AND A BACKUP DEVICE. THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT 2 T6 SELF-HOLD. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404078 ↗
• MalfunctionDec 3, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREWDRIVERS FROM A SET WERE FOUND WORN OUT. THE SET HAS BEEN IN COMMISSION FOR TWO MONTHS. THE REPORTING FACILITY REQUESTED FOR A REPLACEMENT AND A BACKUP DEVICE. THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT 2 T6 SELF-HOLD. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403239 ↗
• MalfunctionSep 27, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE SCREW DRIVERS IN THEIR SETS ARE NOT CAPTURING THE SCREWS CORRECTLY AS THEY HAVE BECOME WORN WITH USE. 2 X 03.130.010 SCREWDRIVER SHAFT STARDRIVE® 1.3/1.5, T4, SELF-HOLDING, FOR HEXAGONAL COUPLING. 2 X 03.130.020 SCREWDRIVER SHAFT STARDRIVE® 2.0, T6, SELF-HOLDING, FOR HEXAGONAL COUPLIN. NO FURTHER ACTION IS REQUIRED AND NO HARM WAS DONE TO ANY PATIENTS. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCRWDRVR SHFT/T6 50MM/SELF-RETAINING/HXC. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9128991 ↗
• MalfunctionSep 27, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE SCREW DRIVERS IN THEIR SETS ARE NOT CAPTURING THE SCREWS CORRECTLY AS THEY HAVE BECOME WORN WITH USE. 2 X 03.130.010 SCREWDRIVER SHAFT STARDRIVE® 1.3/1.5, T4, SELF-HOLDING, FOR HEXAGONAL COUPLING 2 X 03.130.020 SCREWDRIVER SHAFT STARDRIVE® 2.0, T6, SELF-HOLDING, FOR HEXAGONAL COUPLIN. NO FURTHER ACTION IS REQUIRED AND NO HARM WAS DONE TO ANY PATIENTS. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCRWDRVR SHFT/T6 50MM/SELF-RETAINING/HXC. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9128985 ↗
• MalfunctionJan 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH THE VARIABLE ANGLE (VA) HAND SYSTEM FOR A SECOND METATARSAL BONE FRACTURE ON (B)(6) 2019. DURING THE PROCEDURE, THE SURGEON TRIED TO INSERT A SCREW USING THE STARDRIVE SCREWDRIVER SHAFT AND THE DRIVER SHAFT DETACHED FROM THE SCREW. THE SURGEON COMMENTED THAT HE WANTED TO HAVE A SLEEVE TO SUPPORT THE SCREW SINCE IT IS EASILY DETACHED FROM THE DRIVER SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286341 ↗