NA 03.226.041Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982077172), received between Mar 9, 2017 and Feb 18, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER IS BROKEN AT THE TIME OF EXTRACTION THE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376272 ↗
• MalfunctionNov 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE DAY BEFORE THE SURGERY, THE OPERATING ROOM POINTED OUT THAT A TOTAL OF EIGHT ITEMS IN FIVE INSTRUMENT SETS HAD NOT BEEN PROPERLY CLEANED WHEN THEY DELIVERED. ALL THE IMPACTED PRODUCTS OF THE HOLLOW PARTS WERE DIRTY AND APPEARED TO BE BLOOD STAINS. WHEN A BRUSH WAS PASSED THROUGH THE HOLLOW PARTS IN THE OPERATING ROOM, THE BRUSH WAS FOUND TO BE DIRTY, AND SOME INSTRUMENTS WERE SO CLOGGED THAT A BRUSH COULD NOT BE PASSED THROUGH. THE SALES REP ORDERED NEW INSTRUMENTS, HOWEVER MANY OF THEM HAD DROPS OF WATER IN THE HOLLOW PART. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525954 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE THROUGH THE CANNULA. THE ITEM WAS FOUND BROKEN IN STERILE PROCESSING, UNKNOWN WHEN OR HOW THE EVENT OCCURRED. THE FRAGMENT THAT WAS GENERATED HAS NOT BEEN FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356622 ↗
• MalfunctionOct 31, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM EXPERIENCED FAILURE DUE TO WEAR AND TEAR. THE ISSUE WAS NOTED PRE-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20578288 ↗
• MalfunctionJan 12, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER PART BROKE WHEN THE DOCTOR WAS PLACING THE SCREW. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT IS FOR ONE (1) SCRDRIVER CANN T15 F/HCS Ø4.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18505865 ↗
• MalfunctionApr 19, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY USING HCS4.5. DURING USE, THE TIP OF THE SCREWDRIVER BROKE. ANOTHER SCREWDRIVER WAS USED IN THE SURGERY. IT WAS CONFIRMED THAT THERE WAS NO HEALTH HAZARD TO THE PATIENT, THE SURGEON, AND NURSES. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVER CANN T15 F/HCS Ø4.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769385 ↗
• InjuryJul 8, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE TIP OF THE SCREWDRIVER BROKE OFF AND REMAINS INSIDE OF THE PATIENT. THE PATIENT AND PROCEDURE WERE IMPACTED. THIS REPORT IS FOR A CANNULATED STARDRIVE SCREWDRIVER T15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14956987 ↗
• MalfunctionApr 1, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHILE THE LAST SCREW WAS BEING SCREWED INTO THE PATIENT'S BONE SEGMENT, A PORTION OF THE SCREWDRIVER TIP WAS FRACTURED. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS IN GOOD CONDITION. THIS REPORT IS FOR A CANNULATED STARDRIVE SCREWDRIVER T15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981008 ↗
• MalfunctionSep 1, 2021Break; Entrapment of Device; Break; Entrapment of Device

  THE FRAGMENT WAS REMOVED FROM THE PATIENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. CONCOMITANT DEVICE: UNKNOWN HEADLESS COMPRESSION SCREW (PART: UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406888 ↗
• MalfunctionJun 25, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CANNULATED STARDRIVE SCREWDRIVER TIP IS BROKEN, CAN'T ENGAGE AN UNKNOWN SCREW. THE ISSUE WAS OBSERVED DURING PRE-SURGERY. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CANNULATED SDDRIVE SCREWDRIVER T15. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12067319 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER THE DEVICE CAME THROUGH DECONTAMINATION, THE CANNULATED STARDRIVE SCREWDRIVER WAS NOTICED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER T15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8687767 ↗
• MalfunctionJan 9, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN FOOT SURGERY ON (B)(6) 2017, A SCREWDRIVER TIP BROKE DURING IMPLANTATION OF A SCREW. THE BROKEN PIECES WERE REMOVED SUCCESSFULLY. THERE WAS NO PATIENT HARM OR SURGICAL TIME DELAY REPORTED. THIS IS ALL THE INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: CANNULATED SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER T15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176798 ↗
• InjuryMar 9, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRIPLE ARTHRODESIS OF THE ANKLE ON (B)(6) 2017. DURING THE PROCEDURE WHILE THE SURGEON WAS PLACING TWO (2) 4.5 SCREWS INTO THE CALCANEUS, USING A GUIDE WIRE, THE TIP OF THE SCREWDRIVER BROKE OFF AS THE SCREWS WERE BEING TIGHTENED MANUALLY. THE REPORTER WAS UNSURE WHEN THE INSTRUMENT MALFUNCTIONED, IF IT AFTER THE FIRST OR SECOND SCREW PLACEMENT. THE FRAGMENT TIP WAS EASILY RETRIEVED ALTHOUGH THE INCISION LINE HAD TO BE ENLARGED TO LOCATE THE FRAGMENT, THAT WAS DISCARDED. A ROUTINE X-RAY WAS TAKEN THAT CONFIRMED THE FRAGMENT WAS RETRIEVED. THERE WAS 5-10 MINUTE DELAY. NO HARM WAS REPORTED TO THE PATIENT. ANOTHER SIMILAR INSTRUMENT WAS AVAILABLE FOR THE SURGEON TO PLACE ADDITIONAL SCREWS WITHOUT DIFFICULTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES 1 DEVICE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW, UNKNOWN PART AND LOT NUMBERS, QUANTITY X 1 THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6394113 ↗