NA 03.620.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034717432), received between Dec 12, 2016 and Aug 17, 2020 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionAug 17, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PERFORMING A REVISION OF A SPINAL FUSION WHICH CONSISTED OF BILATERAL PEDICLE SCREWS FROM T12 TO L4. WHILE THE SURGEON WAS REMOVING THE SET SCREWS ON THE LEFT L3 SCREW (THE OLD HARDWARE) USING A STARDRIVE SCREWDRIVER, THE TIP OF THE SCREWDRIVER BROKE OFF. UPON SEEING THIS, THE SCREWDRIVER WAS REMOVED, ALONG WITH THE FRAGMENT GENERATED. THE SCREWDRIVER WAS REPLACED WITH A NEW ONE AND THE SURGEON WAS ABLE TO PLACE NEW PEDICLE SCREWS BILATERALLY AT L5, S1 AND INTO THE ILIUM AND IMPLANTED NEW RODS. THERE WERE NO OTHER ISSUES DURING THIS CASE. FRAGMENTS WERE GENERATED AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS AN UNKNOWN AMOUNT OF SURGERY DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10412895 ↗
• InjuryOct 24, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A SCREWDRIVER BROKE DURING A POSTERIOR LUMBAR SPINAL FUSION REVISION ON (B)(6) 2017. INFORMATION WAS NOT PROVIDED ON THE CIRCUMSTANCES LEADING UP TO THE PATIENT BEING REVISED OR IF THE PATIENT HAD PAIN OR DISCOMFORT ASSOCIATED WITH THE EVENT. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. AS THE SURGEON WAS TRYING TO REMOVE A LOCKING CAP, THE TIP OF THE SCREWDRIVER BROKE OFF AND BECAME STUCK INSIDE THE LOCKING CAP. THE SURGEON HAD TO USE AN AIR POWERED DRILL ¿MIDAS REX¿ TO CUT THE LOCKING CAP IN HALF TO GET IT OFF OF THE ROD. THESE EVENTS RESULTED IN A SURGICAL DELAY OF 15-20 MINUTES. NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. NO INFORMATION WAS PROVIDED ON THE DEVICE AGE, NUMBER OF USES, OR ANY CONTRIBUTING FACTORS LEADING TO FAILURE OF THE DEVICE. CONCOMITANT DEVICES REPORTED: AIR POWERED DRILL - MIDAS REX (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY1), TITANIUM MATRIX LOCKING CAP (04.632.000, LOT NUMBER UNKNOWN, QUANTITY 1), ROD (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) STARDRIVER SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Code Available

  MAUDE report 6973934 ↗
• MalfunctionDec 12, 2016Bent; Material Distortion; Bent; Material Distortion

  IT WAS REPORTED THAT IN THE STERILE PROCESSING ROOM, ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC AND ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC-LONG DEVICES WERE BOTH DISCOVERED TO BE BENT UP AND TWISTED DUE TO OVERUSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6168668 ↗