NA 03.010.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982069337), received between Mar 22, 2018 and Sep 14, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionSep 14, 2026Break

  It was reported that during the procedure, while inserting the cap, the tip broke off. This does not cause harm to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759498 ↗
• MalfunctionJun 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH TFNA. THE SURGEON USED THE END CAP AS USUAL BUT POINTED OUT THAT IT DID NOT FIT THE SCREWDRIVER WELL AS IT DID BEFORE AND THERE WAS SOME SLACK. DURING SURGERY, THE END CAP WAS DROPPED INSIDE THE PATIENT'S BODY, BUT IT WAS QUICKLY REMOVED, AND INSERTION WAS COMPLETED. AND THE ANS SCREW ALSO REPORTEDLY DID NOT FIT WELL WITH SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336918 ↗
• MalfunctionJan 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON JANUARY 20, 2025, BEFORE THE SURGERY, IT WAS FOUND THAT THE PRODUCT IN QUESTION WAS HEAVILY SOILED WITH OIL. THE SALES REP WAS ASKED BY THE HOSPITAL TO EXPLAIN THE CAUSE OF THE PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275551 ↗
• MalfunctionDec 22, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS CONFIRMED THAT FOREIGN OBJECTS WERE ADHERED TO THE SCREWDRIVER, THE DRILL BIT, AND THE REAMER WHEN THE STERILIZATION AGENT INSPECTED THE DEVICES. FOREIGN OBJECTS WERE ALSO FOUND IN THE HOLLOW INTERIOR OF THE DEVICES IN QUESTION. ALTHOUGH THE DEVICES WERE FOR THE SURGERY ON (B)(6) 2023, THE SURGERY WAS CANCELLED. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383823 ↗
• MalfunctionJul 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON JUNE 14, 2023, A DISTRIBUTOR MENTIONED THAT DIRT (DEBRIS) WAS FOUND IN THE HOLLOW OF SEVERAL PRODUCTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE CANNULATED STARDRIVE SCREWDRIVER/T40/277MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279933 ↗
• MalfunctionJun 16, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS WORN. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) CANNULATED STARDRIVE SCREWDRIVER/T40/277MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711538 ↗
• MalfunctionDec 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. DURING THE SURGERY, IT WAS VERY HARD TO INSERT AN END CAP WITH THE SCREWDRIVER. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CANNULATED STARDRIVE SCREWDRIVER/T40/277MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925333 ↗
• MalfunctionOct 21, 2021Device-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 THE OSTEOSYNTHESIS SURGERY FOR THE FEMORAL TROCHANTERIC FRACTURE WITH THE SCREWDRIVER IN QUESTION. THE SURGEON USED THE SCREWDRIVER TO INSERT THE ENDCAP, BUT THE ENDCAP COULDN¿T BE INSERTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIFTEEN(15) MINUTES DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1)CANNULATED STARDRIVE SCREWDRIVER/T40/277MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675309 ↗
• MalfunctionJul 16, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE TIP OF THE CANNULATED SCREWDRIVER SPLIT DURING THE INSERTION OF THE COVER SCREW, ENDING THE SURGERY. THERE WAS NO DAMAGE TO THE PATIENT. THIS REPORT IS FOR A CANNULATED STARDRIVE SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12184309 ↗
• MalfunctionJan 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR THE FEMORAL TROCHANTERIC FRACTURE WITH THE FLEXIBLE SCREWDRIVER. DURING THE SURGERY, THE SURGEON USED THE SCREWDRIVER TO INSERT THE ENDCAP, BUT THE ENDCAP COULDN¿T BE INSERTED. HE TRIED TO INSERT TWO ENDCAPS (0MM AND 5MM), BUT BOTH COULDN¿T BE INSERTED. THE SURGERY WAS COMPLETED WITHOUT INSERTING THE ENDCAP WITHIN THIRTY (30) MINUTES DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: TFNA END CAP (PART# 04.038.000S; LOT# 63P1560; QUANTITY 1); TFNA END CAP (PART# 04.038.005S; LOT# 47P6785; QUANTITY 1), TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER/T40/277MM. THIS IS REPORT 1 OF 3 FOR (B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205225 ↗
• MalfunctionDec 1, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE CANNULATED STARDRIVE SCREWDRIVER WAS BROKEN. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER/T40/277MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928689 ↗
• MalfunctionJan 28, 2019Device Difficult to Maintain; Device Difficult to Maintain

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN SURGERY A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM WAS APPLIED FOR FEMORAL TROCHANTERIC FRACTURES. DURING SURGERY, THE SURGEON HAD A DIFFICULTY IN INSERTION AND TIGHTENING AN END CAP USING A SCREWDRIVER DUE TO FOLLOWING REASONS: (1) THE PITCH OF THREADS ON AN END CAP IS SHORT, THUS CLEARANCE WAS SMALL; (2) AN END CAP WAS DETACHED FROM THE DRIVER SHAFT; (3) DUE TO AN UNKNOWN GUIDE WIRE WITH HOOK, AN ACCEPTABLE RANGE OF ANGLE FOR INSERTING THE END CAP WAS LIMITED; (4) AND THE TIP OF THE DRIVER SHAFT COULD NOT BE BENT. SO, THE SURGEON REQUESTED TO CHANGE THE DESIGN AS FOLLOWS: MAKE THE THREAD PITCH LONGER, CHANGE THE DESIGN SO THAT THE SCREW IS HELD WITH THE SCREWDRIVER FIRMLY, AND CHANGE THE DESIGN SO THAT THE ACCEPTABLE RANGE OF THE END CAP INSERTION BECOMES WIDER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTES SURGICAL DELAY REPORTED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDE WIRE ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) UNKNOWN SCREWDRIVER SHAFT ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1

  Patient problems: No Patient Involvement

  MAUDE report 8283602 ↗
• MalfunctionJan 10, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRIA AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE CANNULATED STARDRIVE SCREWDRIVER FOR END CAP BROKE DURING INSERTION OF THE UNKNOWN END CAP. THE SURGEON USED ANOTHER STARDRIVE SCREWDRIVER FROM ANOTHER TFNA SET TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF UNSPECIFIED MINUTES. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: END CAP (PART#: UNKNOWN, LOT #: UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8233248 ↗
• MalfunctionMar 22, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, THAT BEFORE THE SURGERY IT WAS FOUND THERE WAS BLOOD OR RUST LIKE STAIN ON THE SCREWDRIVER. THE SCREWDRIVER IN QUESTION WAS NOT USED IN THE SURGERY. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363383 ↗