NA 03.110.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982071934), received between Mar 12, 2020 and Nov 24, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DOCTOR WAS USING THE RATCHET SCREW DRIVER OUT OF THE DISTAL RADIUS SYSTEM. HE WAS UNABLE TO FLIP THE SWITCH TO ADJUST THE RATCHET ASPECT OF THE SCREW DRIVER. ALSO FOLLOWING THE CASE, THE SCREW DRIVER BLADE WAS UNABLE TO BE DISCONNECTED FROM THE BLACK RATCHET HANDLE. A DIFFERENT SCREWDRIVER WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) SD SCRDRIVER SFT T8 FOR RATCHETING H&LE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204613 ↗
• MalfunctionJul 21, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP BROKE OFF OF THE DEPTH GAUGE AND THE TIP OF THE SCREWDRIVER WAS STRIPPED. THERE WERE NO REPORTED PATIENT CONSEQUENCES, NO ADVERSE PATIENT OUTCOME. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T8 FOR RATCHETING HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370621 ↗
• MalfunctionSep 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE POST OP INSPECTION OF ITEMS WERE CANDY CANED, OR WARPED FROM OVER USAGE. MALLET HAD A ROUGH ETCHING AND BACKSLAP HAD THREADS WORN OUT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1)SD SCRDRIVER SFT T8 FOR RATCHETING H&LE THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336841 ↗
• MalfunctionSep 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE POST OP INSPECTION OF ITEMS WERE CANDY CANED, OR WARPED FROM OVER USAGE. MALLET HAD A ROUGH ETCHING AND BACKSLAP HAD THREADS WORN OUT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1)SD SCRDRIVER SFT T8 FOR RATCHETING H&LE. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336840 ↗
• MalfunctionNov 23, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A TIBIAL PROCEDURE, (1) 3.5 LCP TIBIAL PLATE AND (1) STARDRIVE SCREWDRIVER WERE STRIPPED. THE LOCKING HOLE WAS STRIPPED IN THE PLATE DURING PERCUTANEOUS DRILLING AND THE STARDRIVE SCREWDRIVER WAS STRIPPED AFTER OVERTORQUE OF INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) STARDRIVE SCREWDRIVER SHAFT T8 FOR RATCHETING HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860703 ↗
• MalfunctionApr 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RATCHETING SCREWDRIVER HANDLE WOULD NOT HOLD THE T8 SCREWDRIVER BLADE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 FOR RATCHETING HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665493 ↗
• MalfunctionJun 30, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING WASHING AND STERILIZING, TWO (2) SCREWDRIVER SHAFTS WERE NOTICED TO HAVE DAMAGED TIPS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 FOR RATCHETING HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10211581 ↗
• MalfunctionMar 12, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, THE TIP OF STARDRIVE SCREWDRIVER SHAFT FOR RATCHETING HANDLE WAS BROKEN OFF. THE ISSUE WAS NOTICED UPON INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 FOR RATCHETING HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9823498 ↗