NA 351.16Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982193735), received between Mar 17, 2017 and Apr 21, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE REAMER QUICK CONNECT WAS FOUND BROKEN POSTOPERATIVELY. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873877 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE REAMER QUICK CONNECT WAS FOUND BROKEN POSTOPERATIVELY. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873876 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM LOCKED UP/BROKEN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777835 ↗
• MalfunctionJan 27, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING STERILE PROCESSING DEPARTMENT (SPD), TWO (2) FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633316 ↗
• MalfunctionJan 27, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING STERILE PROCESSING DEPARTMENT (SPD), TWO (2) FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9633310 ↗
• MalfunctionDec 9, 2019Break; Break

  THIS REPORT IS FOR A FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK.

  Patient problems: No Patient Involvement

  MAUDE report 9439973 ↗
• MalfunctionOct 26, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE FLEXIBLE SHAFT CONNECTOR WAS BROKEN. IT DID NOT AFFECT THE PATIENT AND THE SURGERY. THIS COMPLAINT INVOLVES (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8009347 ↗
• MalfunctionMar 17, 2017Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL NAILING PROCEDURE ON (B)(6) 2017, THE SURGEON WAS GOING TO USE A FLEXIBLE SHAFT CONNECTOR WITH HAND DRILL BUT IT WAS FOUND BROKEN. IT WAS UNKNOWN WHEN THE DEVICE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT HARM. THIS CASE IS LINKED TO (B)(4). THIS REPORT IS FOR ONE (1) FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6414505 ↗