NA SD388.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034706252), received between Mar 22, 2018 and Mar 22, 2018 — classified as 2 malfunctions.

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

• MalfunctionMar 22, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INSPECTION OF FIELD EQUIPMENT ON (B)(6) 2018, IT WAS NOTED THAT TWO 3.5MM/4.0MM STARDRIVE SELF RETAINING SCREW DRIVER TIPS WERE TWISTED AND WARPED AS THOUGH THEY HAD BEEN USED TO OVERTIGHTEN A SCREW WHEN LAST USED. IT IS UNKNOWN WHEN OR WHERE THE DEVICE DAMAGE OCCURRED. IT WAS CONFIRMED THAT THE DEVICE DID NOT MALFUNCTION DURING A PROCEDURE AND DID NOT IMPACT ANY SURGERY OR HARM ANY PATIENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7361743 ↗
• MalfunctionMar 22, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INSPECTION OF FIELD EQUIPMENT ON (B)(6) 2018, IT WAS NOTED THAT TWO 3.5 MM/4.0 MM STARDRIVE SELF RETAINING SCREW DRIVER TIPS WERE TWISTED AND WARPED AS THOUGH THEY HAD BEEN USED TO OVERTIGHTEN A SCREW WHEN LAST USED. IT IS UNKNOWN WHEN OR WHERE THE DEVICE DAMAGE OCCURRED. IT WAS CONFIRMED THAT THE DEVICE DID NOT MALFUNCTION DURING A PROCEDURE AND DID NOT IMPACT ANY SURGERY OR HARM ANY PATIENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7361738 ↗