NA 03.113.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982072856), received between Jun 4, 2019 and Jul 8, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SCREWDRIVER SHAFT STARDRIVE 165MM. THIS IS REPORT 1 OF 8 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19694209 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT INVOLVES ONE SCREWDRIVER SHAFT STARDRIVE 165MM. THIS IS REPORT 9 OF 9 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4) AND (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689276 ↗
• MalfunctionFeb 5, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: . IT WAS REPORTED THAT ON (B)(6) 2024, THE MALE PATIENT UNDERWENT ORIF WITH PHILOS IMPLANT FOR HUMERUS FRACTURE. DURING THE SURGERY, LOCKING SCREW WAS BEING INSERTED WITH THE POWER TOOL, BUT THE SCREWHEAD WAS EXCESSIVELY LOCKED IN THE PLATE DUE TO AN EXTRA FORCE, SO SCREWDRIVER¿S TIP WAS BROKEN OFF AND IT REMAINED IN THE SCREWHEAD. IT WAS IMPOSSIBLE FOR A REMOVAL FOR THE TIP IN QUESTION, EVEN THOUGH A HOSPITAL-OWN DRILL AND AN AIRTOME WERE TRIED TO BE USED FOR THE REMOVAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT 3.5 T15 LONG SELF-HOLDING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647040 ↗
• MalfunctionJan 22, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON THE SALES REP TURNED OVER THE SURGICAL INSTRUMENT TRAY AND THE TIP OFF THE SCREWDRIVER WAS TWISTED. IT WAS NOT FUNCTIONAL ANYMORE AND WANTED TO START THE REPLACEMENT PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT 3.5 T15 LONG SELF-HOLDING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554192 ↗
• MalfunctionAug 28, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING STERILE PROCESSING STRIPPED STARDRIVE SCREWDRIVER. THERE WAS NO PATIENT INVOLVEMENT, ITEM FOUND AND DISCARDED BY HOSPITAL AFTER ITEM WAS DEEMED STRIPPED AND UNUSABLE. THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT SDDRIVE 165MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17634519 ↗
• MalfunctionOct 4, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE PRODUCT DID NOT LOOSEN THE SCREW. IT CAUSED IT TO LOOSEN AND CHANGE DIRECTION ON LONG SCREWS, AND THE SCREW HEADS WERE DAMAGED BY NOT SELF-CLAMPING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SCREWDRIVER SHAFT STARDRIVE 165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536016 ↗
• MalfunctionMay 6, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE SCREW DRIVER WAS FOUND TO BE WARPED AT THE TIP. PATIENT INVOLVEMENT WAS UNKNOWN. SURGICAL WAS ALSO UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE SCREWDRIVER SHAFT SDDRIVE 165MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14308282 ↗
• InjuryMar 1, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR LEFT HUMERUS SURGICAL NECK FRACTURE. WHEN THE SURGEON WAS FIXING A PLATE WITH A SCREW USING THE SCREWDRIVER IN QUESTION, THE SCREWDRIVER BROKE. THE BROKEN PART OF THE SCREWDRIVER BURIED IN THE SCREWHEAD, AND IT WAS IMPOSSIBLE TO REMOVE THE SCREW FROM THE PLATE. THEREFORE, THE SURGEON LEFT THE SCREW AS IT IS, REMOVED THE OTHER SCREWS OUT OF THE PLATE, AND PULLED THE PLATE OUT VERTICALLY TOGETHER WITH THE UNREMOVABLE SCREW. AFTER THAT, THE SURGEON TRIED TO REMOVE THE UNREMOVABLE SCREW FROM THE PLATE USING SOME INSTRUMENTS, BUT HE COULDN¿T. THE SURGEON GAVE UP USING THE PLATE AND USED ANOTHER NEW PLATE FOR THIS TREATMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT STARDRIVE 165MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13636889 ↗
• MalfunctionOct 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 THAT THE SIZER WOULD NOT GRIP THE CORTEX TO MEASURE AND THE STARDRIVE WAS TOO WORN TO GRIP THE SCREW. CONCOMITANT MEDICAL PRODUCTS: UNK - SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT STARDRIVE 165MM. THIS IS REPORT 2 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674744 ↗
• MalfunctionSep 14, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION, THE FOLLOWING DEVICES WERE SET ASIDE FOR COMPLAINTS: THE HANDLE WITH QUICK COUPLING HAS A CRACKED, DEPTH GAUGE NEEDLE POPPED OFF, TWO STARDRIVE SCREWDRIVER SHAFT WAS WARPED, AND ONE SCREWDRIVER WAS FLATTENED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (5) DEVICES. THIS REPORT IS FOR (1) SCREWDRIVER SHAFT SDDRIVE 165MM. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469337 ↗
• MalfunctionNov 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SCREWDRIVER SHAFT WAS UNABLE TO ENGAGE WITH THE SCREW RECESS. THE SURGEON USED ANOTHER SCREWDRIVER SHAFT IN THE SET TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT STARDRIVE 165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10878161 ↗
• MalfunctionJul 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS ALSO REPORTED THAT DUE TO REPORTED ISSUE THE LOCKING COMPRESSION PLATE (LCP) CAST COULD NOT BE USED PROPERLY, EXTENDING THE SURGERY SINCE THE PLACEMENT OF THE BLOCKED SCREWS AND THE VA VARIABLE ANGLE SYSTEM WERE COMPLICATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10225526 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE SCREWDRIVER SHAFT STARDRIVE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880311 ↗
• MalfunctionJun 4, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE STEEL ON THE DRILL BIT WAS DAMAGED AND IRREGULAR. ONE (1) STARDRIVE SCREWDRIVER SHAFT AND ONE (1) SHORT STARDRIVE SCREWDRIVER SHAFT WERE NOT RETAINING UNKNOWN SCREWS PROPERLY AND SEEMED TO BE STRIPPING DURING AN UNKNOWN PROCEDURE. THERE WAS A BACK UP INSTRUMENTS USED TO COMPLETE THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT STARDRIVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666999 ↗