NA 351.15Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982193728), received between Mar 3, 2017 and Oct 9, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN SPD INSPECTION/FIELD INSPECTION, THERE WAS A PIECE MISSING WHICH IS WHY IT'S BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408281 ↗
• MalfunctionOct 6, 2023Break; Crack; Break; Crack

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING STERILIZATION ON 20-SEPTEMBER-2023, THE T-HANDLE IN QUESTION WAS FOUND TO HAVE CRACKED. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886346 ↗
• MalfunctionMar 7, 2023Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE T-HANDLE IN QUESTION FROM THE STREAM SET HAD BROKEN. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496854 ↗
• MalfunctionMay 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT FOR A SURGERY. DURING THE PROCEDURE, THE NITINOL SHAFT BENT FROM REAMERS AND T HANDLE DOESN'T CONNECT. THERE WERE 3 MINUTES SURGICAL DELAY. THE SURGERY AND THE PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) FLEXIBLE SHAFT HANDLE QUICK COUPLING. THIS REPORT IS 1 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888807 ↗
• MalfunctionMay 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT FOR A SURGERY. DURING THE PROCEDURE, THE NITINOL SHAFT BENT FROM REAMERS AND T HANDLE DOESN¿T CONNECT. THERE WERE 3 MINUTES SURGICAL DELAY. THE SURGERY AND THE PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) FLEXIBLE SHAFT HANDLE QUICK COUPLING. THIS REPORT IS 3 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888771 ↗
• MalfunctionSep 3, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A PROCEDURE INVOLVING IM RODDING OF TIBIA, THE FLEXIBLE SHAFT HANDLE BROKE OFF DURING INSERTION/ROTATION. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT HANDLE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488505 ↗
• MalfunctionOct 25, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION, TWO (2) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS TIP WERE BENT AND LOOSE, ONE (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE ROUND EDGE HANDLE WAS CRACKING, ONE (1) SCREWDRIVER BLADE WITH HOLDING SLEEVE SHORT DRIVER GETS STUCK IN THE HOLDER, ONE (1) TORQUE LIMITING ATTACHMENT HAS A MISSING TIP, ONE (1) TRIGGER HANDLE/ CABLE CUTTER HAS A MISSING PIECE IN THE HANDLE, AND ONE (1) T-HANDLE WOULD NOT GO BACK/ STAY TOGETHER, LIKELY MISSING PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T-HANDLE W/QUICK-COUPL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9238280 ↗
• MalfunctionOct 8, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL OWENS & MINOR (B)(4) SITE ON AN UNKNOWN DATE, A FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING WAS OBSERVED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9168153 ↗
• MalfunctionAug 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY FEMUR ROD PROCEDURE ON (B)(6) 2019, IT WAS NOTICED THAT THE FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING ATTACHMENT FOR REAMER WOULD NOT ATTACH. UPON FURTHER EXAMINATION, THE INNER OF THE DEVICE METAL PIN IS MISSING. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8894901 ↗
• MalfunctionMar 3, 2017Break; Break

  IT WAS REPORTED THAT A FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING WAS FOUND BROKEN IN CENTRAL STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6378103 ↗