NA 03.230.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982077271), received between Sep 4, 2018 and Apr 3, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF SURGERY FOR DISTAL PROXIMAL PHALANX FRACTURE WITH TWO HEADLESS COMPRESSION SCREW 1.5 IN QUESTION. AFTER THE FRACTURE WAS REDUCED AND TEMPORARILY FIXED WITH K-WIRE, IT WAS FIXED WITH TWO 1.5 MM HCS FROM THE DISTAL ARTICULAR SURFACE (IP JOINT). THE FIRST SCREW WAS DRILLED USING 1.1 MM DRILL BIT AND INSERTED. WHILE MODERATE PRESSURE WAS APPLIED, THE DRIVER WAS REPLACED, AND THE HEAD PART OF THE SCREW WAS BURIED IN THE BONE. APPROPRIATE PRESSURE WAS APPLIED TO THE SECOND SCREW AS WELL, AND THE SCREW WAS INSERTED AFTER REPLACING THE DRIVER. IT WAS CONFIRMED BY PALPATION THAT THE HEAD PART WAS BURIED, BUT IT WAS NOT COMPLETELY BURIED, SO THE SCREWDRIVER IN QUESTION WAS USED TO TRY TO BURY IT AGAIN BECAUSE OF THE JOINT SURFACE. IT WAS HARD AND GOOD BONE QUALITY, BUT THE HEAD PART WAS NOT COMPLETELY BURIED EVEN THOUGH AND THE HEAD PART OF THE SCREW WAS REINSERTED CAREFULLY WITH AXIAL PRESSURE. THEREFORE, AN ATTEMPT WAS MADE TO REMOVE THE SCREW ONCE, BUT THE TIP OF THE SCREWDRIVER WAS TWISTED AND DAMAGED, MAKING IT IMPOSSIBLE TO REMOVE. SOME TROUBLESHOOTING WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664506 ↗
• MalfunctionFeb 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE INSERTING THE SCREW AND APPLYING THE TORQUE TO THE SCREWDRIVER, THE TIP OF THE SCREW DRIVER TWISTED MAKING IT UNABLE TO BE USED. A NEW SET WAS OPENED AND THE PROCEDURE WAS SUCCESS FULLY COMPETED. THERE WAS NO SURGICAL DELAY REPORTED. CONCOMITANT DEVICES: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN TORQUE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT FOR 1.5MM HCS T4. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307541 ↗
• InjurySep 4, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A HARDWARE REMOVAL SURGERY. DURING THE SURGERY, A STARDRIVE SCREWDRIVER SHAFT BROKE OFF IN THE SCREW HEAD WHILE ATTEMPTING TO REMOVE A HEADLESS COMPRESSION SCREW THAT HAD BACKED OUT INTO THE KNEE JOINT. THE SCREW WAS ORIGINALLY IMPLANTED SEVERAL YEARS AGO. THE SURGEON HAD TO REMOVE THE SCREW BY DRILLING OVER IT. THIS CAUSED AN UNKNOWN LENGTH OF SURGICAL DELAY AND MORE X-RAYS HAD TO BE TAKEN. PATIENT AND PROCEDURE OUTCOMES WERE UNKNOWN. (B)(4) WILL CAPTURE THE INTRA-OPERATIVE EVENTS, WHERE THE STARDRIVE SCREWDRIVER SHAFT BROKE. (B)(4) WILL CAPTURE THE POST-OPERATIVE EVENTS, WHERE AN IMPLANT WAS FOUND OUT TO HAVE BACKED OUT. CONCOMITANT DEVICE REPORTED: 1.5MM HEADLESS COMPRESSION SCREW: (PART# UNKNOWN, LOT# UNKNOWN, QTY# 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT FOR 1.5MM HCS T4. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7842012 ↗