NA 393.101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982198990), received between Nov 28, 2022 and Jun 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 25, 2026Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT SHORT T8 SCREWDRIVER STRIPPED, AND MULTIPLE ITEMS RUSTING PER SPD, CAUSING SETS TO NOT BE PUT UP FULL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622375 ↗
• MalfunctionNov 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE NURSING STAFF INDICATED SHANE PIN ADAPTORS WERE SLIPPING AND NOT FUNCTIONING PROPERLY. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) DRIVE ADAPTOR QC FOR 4.0 SCHANZ SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15873761 ↗