NA 03.114.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982073044), received between Jul 24, 2017 and Mar 3, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A VETERINARY SURGERY, THE SCREWS DID NOT TIGHTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21506180 ↗
• MalfunctionJul 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HONG KONG AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE T4 SCREWDRIVER COULD NOT REMOVE THE 1.5 STARDRIVE COMPACT HAND LOCKING AND CORTEX SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SCREWDRIVER. THERE WAS A DELAY OF UNKNOWN LENGTH. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER SHAFT T4/66MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371652 ↗
• 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 SDDRIVE SCREWDRIVER SHAFT T4/66MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704269 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER BECAME STRIPPED AND WAS NOT ABLE TO ADVANCE SCREWS INTO THE PLATE. IN THE SAME SURGERY A SEPARATE SCREWDRIVER GOT STUCK INSIDE THE SCREWDRIVER HANDLE AND WOULD NOT COME LOOSE. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5 MINUTES. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT T4/66MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644574 ↗
• MalfunctionAug 11, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SCREWDRIVER HEAD IS DAMAGED AND NEEDS REPLACEMENT. THIS REPORT IS FOR 1 STARDRIVE SCREWDRIVER SHAFT T4/66MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393331 ↗
• MalfunctionDec 23, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION IT WAS NOTICED THAT THE STARDRIVE SCREWDRIVER SHAFT WERE SLIGHTLY STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9512125 ↗
• MalfunctionDec 17, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THE PROCEDURE BEING PERFORMED WAS AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE INDEX FINGER.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9485451 ↗
• 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 T4/66MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282764 ↗
• MalfunctionMay 24, 2018Bent; Material Twisted/Bent; Bent; Material Twisted/Bent

  IT WAS REPORTED THE STARDRIVE SCREWDRIVER SHAFT WAS NOTED TO BE BENT PRIOR TO THE START OF A SURGICAL PROCEDURE. THE DEVICE WAS REMOVED FROM THE SET, NO PATIENT OR SURGICAL INVOLVEMENT. THE RESULTS OF THE INVESTIGATION OF THE RETURNED DEVICE REVEALED THE DISTAL TIP IS TWISTED AND ROUNDED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7540384 ↗
• MalfunctionMar 2, 2018Bent; Bent

  IT WAS REPORTED TWO T4 STAR SCREWDRIVERS BENT DURING A BOXER¿S FRACTURE (A FOURTH AND FIFTH METACARPAL FRACTURE) REPAIR PROCEDURE ON (B)(6) 2018. AFTER PILOT HOLES HAD BEEN DRILLED, AS THE SURGEON WAS IMPLANTING 1.5 MM LOCKING SCREWS THROUGH A PLATE, THE TWO SCREWDRIVERS BENT. A THIRD SCREWDRIVER BLADE WAS AVAILABLE FOR USE. THERE WAS A SURGICAL DELAY OF A FEW SECONDS TO SWITCH TO ANOTHER SCREWDRIVER. THE FINAL CONSTRUCT INCLUDED PLATES AND SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES: UNKNOWN 1.5 MM LOCKING SCREWS: (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN LOCKING PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7309582 ↗
• MalfunctionMar 2, 2018Bent; Bent

  IT WAS REPORTED TWO T4 STAR SCREWDRIVERS BENT DURING A BOXER¿S FRACTURE (A FOURTH AND FIFTH METACARPAL FRACTURE) REPAIR PROCEDURE ON (B)(6) 2018. AFTER PILOT HOLES HAD BEEN DRILLED, AS THE SURGEON WAS IMPLANTING 1.5MM LOCKING SCREWS THROUGH A PLATE, THE TWO SCREWDRIVERS BENT. A THIRD SCREWDRIVER BLADE WAS AVAILABLE FOR USE. THERE WAS A SURGICAL DELAY OF A FEW SECONDS TO SWITCH TO ANOTHER SCREWDRIVER. THE FINAL CONSTRUCT INCLUDED PLATES AND SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES: UNKNOWN 1.5MM LOCKING SCREWS: (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN LOCKING PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7309515 ↗
• MalfunctionDec 7, 2017Peeled/Delaminated; Device Operates Differently Than Expected; Peeled/Delaminated; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THERE WAS AN ISSUE WITH A SCREWDRIVER. THE SURGERY COMPLETED THE PROCEDURE BY USING AN ALTERNATIVE DRIVER. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY. THE DRIVER DID NOT ENGAGE PROPERLY WITH THE SCREW AND STRIPPED THE HEAD OF THE SCREW. THERE WAS NO PATIENT HARM AND THE IMPLANT WAS PUT INTO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. TWO DRIVERS FAILED. THIS COMPLAINT INVOLVES 2 PARTS. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7097078 ↗
• MalfunctionDec 7, 2017Peeled/Delaminated; Device Operates Differently Than Expected; Peeled/Delaminated; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THERE WAS AN ISSUE WITH A SCREWDRIVER. THE SURGERY COMPLETED THE PROCEDURE BY USING AN ALTERNATIVE DRIVER. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY. THE DRIVER DID NOT ENGAGE PROPERLY WITH THE SCREW AND STRIPPED THE HEAD OF THE SCREW. THERE WAS NO PATIENT HARM AND THE IMPLANT WAS PUT INTO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. TWO DRIVERS FAILED. THIS COMPLAINT INVOLVES 2 PARTS. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7097051 ↗
• InjuryDec 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017, TWO (2) STARDRIVE SCREWDRIVER SHAFT T4/66MM WOULD NOT ENGAGE ON THE HEADS OF THE 1.5MM MODULE CORTEX SCREWS. BECAUSE OF THIS THE SURGEON HAD TO REMOVE THE PLATE AND SCREWS. PATIENT DID NOT RECEIVE A PLATE ON FINGER. INSTEAD, TWO (2) KIRSCHNER WIRES WERE USED. THERE WAS A SURGICAL DELAY OF ABOUT 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: CORTEX SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) (B)(4).

  Patient problems: No Code Available

  MAUDE report 7084833 ↗
• InjuryDec 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017, TWO (2) STARDRIVE SCREWDRIVER SHAFT T4/66MM WOULD NOT ENGAGE ON THE HEADS OF THE 1.5MM MODULE CORTEX SCREWS. BECAUSE OF THIS THE SURGEON HAD TO REMOVE THE PLATE AND SCREWS. PATIENT DID NOT RECEIVE A PLATE ON FINGER. INSTEAD, TWO (2) KIRSCHNER WIRES WERE USED. THERE WAS A SURGICAL DELAY OF ABOUT 5MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: CORTEX SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7084712 ↗
• MalfunctionNov 2, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2017, A STARDRIVE SCREWDRIVER WAS NOT ABLE TO REMOVE THE DRILL GUIDE FROM A 1.5 MM LOCKING COMPRESSION PLATE (LCP)-Y PLATE WITH GUIDES. THE PLATE IN GENERAL HAS PRE-LOADED DRILL GUIDES WHICH COULD NOT BE REMOVED BY THE SCREWDRIVER BEFORE THE PLATE WAS IMPLANTED IN THE PATIENT. THE PLATE WAS REPORTED TO BE INTACT, WHEREAS THE STARDRIVE SCREWDRIVER DID NOT SHOW ANY VISIBLE DEFORMATION OR OTHER PHYSICAL FAULTS. FAILING THE ATTEMPT OF REMOVING THE DRILL GUIDE, A DIFFERENT PLATE WAS USED. IT IS UNCLEAR IF THE SAME OR A DIFFERENT SCREWDRIVER WAS USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATE TWO (2) MINUTE SURGICAL DELAY. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. RETURNED DEVICE WAS EVALUATED BY CUSTOMER QUALITY ON (B)(6) 2017. COMPLAINT WAS REASSESSED BASED ON THAT EVALUATION AND DEEMED TO BE A REPORTABLE EVENT. THIS REPORT IS FOR ONE (1) STARDRIVER SCREWDRIVER SHAFT T4/66MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6998288 ↗
• MalfunctionJul 24, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED, ON (B)(6) 2017, DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A METACARPAL FRACTURE, THE SURGEON WAS HAVING TROUBLE INSERTING SCREWS. THE SCREWS WERE SPINNING ON THE SCREWDRIVER. UPON INSPECTION, THE TIP OF THE SCREWDRIVER APPEARED ROUNDED, NOT BROKEN. A BACK-UP SCREWDRIVER WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). 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 6736348 ↗