NA 03.010.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982067821), received between Feb 7, 2018 and Nov 14, 2024 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 14, 2024Crack; Crack

  IT WAS REPORTED THAT ON SEPTEMBER 26, 2024, THE HANDLES WERE CRACKED. THERE WAS NO PATIENT AND OPERATION INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS FOUND THAT THE DEVICE WAS BROKEN FROM THE BROWN HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684902 ↗
• MalfunctionNov 14, 2024Crack; Crack

  IT WAS REPORTED THAT ON SEPTEMBER 26, 2024, THE HANDLES WERE CRACKED. THERE WAS NO PATIENT AND OPERATION INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS FOUND THAT THE DEVICE WAS BROKEN FROM THE BROWN HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684897 ↗
• MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE SCREWDRIVER IN QUESTION WAS FOUND TO BE DIRTY. AT THE TIME OF PLACING THE CLOSURE CAP AND PASSING THE GUIDE NEEDLE, ORGANIC MATTER CAME OUT. THE INSTRUMENT WAS DEEMED TO BE CONTAMINATED, TSPIN COULD NOT BE PLACED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18101421 ↗
• InjuryJul 20, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ETN SET MARKED FOR ETN PIN EXTRACTION. ALSO SENT ILN UNIVERSAL PIN EXTENSION SET. IT WAS SENT FROM ILN, AND INSTEAD OF SENDING THE ETN EXT SET SENT THE SET OF EXT BROKEN PINS. ANESTHETIZED PATIENT AND SURGEON WITHOUT MATERIAL TO EXTRACT THE PIN .SURGERY TOOK LONG, OPENED SETS AND SETS OF MATERIAL TO TRY TO FIND A SOLUTION THAT ALLOWED THE IMPLANT TO BE REMOVED. DAMAGED PARTS BELONGING TO OTHER INSTRUMENTS. THE PRODUCT COMPLAINT (B)(4) WAS OPENED ON (B)(6) 2022, FOR A DAMAGED PRODUCT. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) SCRDRIVER T40 CANN L300. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15065108 ↗
• MalfunctionJan 6, 2022Device-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, THE PATIENT UNDERWENT FOR A SURGERY. IN THE SURGERY, IT WAS DIFFICULT TO INSERTING THE END CAP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 10-MINUTES DELAY. THE PATIENT CONDITION WAS STABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178182 ↗
• MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DIAPHYSEAL FRACTURE OF TIBIA. BEFORE THE SURGERY DURING STERILIZATION, IT WAS FOUND THAT AN UNKNOWN OILY LIQUID SUBSTANCE CAME OUT OF THE SCREWDRIVERS. THE SUBSTANCE DOES NOT APPEAR AT THE TIME OF SECOND STERILIZATION. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVER T40 CANN L300. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474773 ↗
• MalfunctionAug 4, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE TIBIAL SHAFT FRACTURE WITH THE SCREWDRIVER. BEFORE THE SURGERY, AFTER THE STERILIZATION OF THE DEVICES, UNKNOWN OILY BROWN LIQUID CAME OUT OF THE SCREWDRIVER. THE LIQUID SPREAD TO THE CASE AND PENETRATED TO THE SECOND STAGE OF THE CASE. WHEN THE INSTRUMENTS WERE WASHED AND STERILIZED AGAIN, NO LIQUID WAS FOUND, AND THE OPERATION WAS CONTINUED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR (1) CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274899 ↗
• MalfunctionJul 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION IT WAS NOTICED THAT ONE (1) STARDRIVE SCREWDRIVER'S END WAS PITTED, AND ONE (1) STRAIGHT PELVIC OSTEOTOME'S BLADE ON THE END WAS PITTED. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICES IT WAS OBSERVED THAT THE DISTAL TIP- THREADED PORTION WAS FOUND TO BE ROUNDED/WORN. THIS DEVICE CONDITION WAS REASSESSED AND DETERMINED TO BE REPORTABLE ON JULY 1, 2020. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10254827 ↗
• MalfunctionJun 11, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR RIGHT TIBIA DIAPHYSIS FRACTURES USING THE EXPERT TIBIAL NAIL SYSTEM. BEFORE THE SURGERY THE HOSPITAL FOUND THAT THE CASE HAD BEEN TAINTED IN A BROWN COLOR. LATER, THEY FOUND THAT THE DISPOSABLE SHEET TO WRAP THIS CASE HAD ALSO BEEN TAINTED IN A BROWN COLOR. THEY DID NOT FIND ANY BREAKAGE THAT WOULD LEAD TO A PROBLEM. THEY WIPED DOWN THE CASE AND THEN USED THE INSTRUMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10144212 ↗
• MalfunctionSep 30, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT IT WAS DISCOVERED DURING AN INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9135665 ↗
• InjurySep 13, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, BEFORE THE SURGERY WITH EXPERT TIBIAL NAIL, THE HOSPITAL STERILIZED THE SCREWDRIVERS AND THE COMBINED HAMMER IN QUESTION. AFTER THE STERILIZATION, AN UNKNOWN BROWN OILY LIQUID HAD SEEPED OUT AND STAINED A CASE. THE PART OF THE CASE, IN WHICH THE PHENOLIC RESIN PRODUCT WAS PLACED, WAS STAINED. THE DEVICES WERE NOT USED IN THE SURGERY BECAUSE A SURGEON USED A PLATE. THE HOSPITAL DIDN¿T CLEAN THE DEVICES BEFORE STERILIZATION. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9025113 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, A PIECE OF THE WOODEN HANDLE OF THE CANNULATED STAR DRIVE SCREWDRIVER CHIPPED OFF DURING CLEANING IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8885025 ↗
• MalfunctionNov 16, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, IT WAS FOUND OUT THAT DURING INSPECTION, THE SCREWDRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8081608 ↗
• MalfunctionAug 15, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER STERILIZATION ON (B)(6) 2018, THE WOODEN INSTRUMENTS IN THE TIBIA EX SET, NAMELY, THE BALL HEX SCREWDRIVER, STARDRIVE SCREWDRIVER AND THE CANNULATED STARDRIVE SCREWDRIVER, WERE BLEEDING A RESIDUE IN THE TRAYS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7786614 ↗
• MalfunctionFeb 7, 2018Break; Break

  IT WAS REPORTED THAT A CANNULATED STARDRIVE BROKE DURING SURGERY ON (B)(6) 2018. THE SURGEON WAS TRYING TO TAKE OUT AN END CAP WHEN THE WHOLE HANDLE BROKE LOOSE. THERE WAS A 30-MINUTE DELAY IN SURGERY. PROCEDURE COMPLETED SUCCESSFULLY AND PATIENT WAS IN STABLE CONDITION. CONCOMITANT DEVICE: END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7247711 ↗