NA 698327038Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034314303), received between Jan 6, 2020 and Mar 30, 2021 — classified as 4 injuries, 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING POSTERIOR SPINAL FUSION SURGERY OF A LARGE PATIENT WITH VERY HARD BONE REQUIRING A LOT OF TORQUE ON INSTRUMENTS FOR HARDWARE REMOVAL/PLACEMENT. FRAGMENT AT TIP OF SCREWDRIVER BROKE OFF IN THE SCREW AND WAS EASILY REMOVED WITH A SIMPLE ¿KELLY CLAMP¿. THERE WAS A SURGICAL DELAY OF 1 MINUTE. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE ITEM FROM THE PATIENT AND WAS REMOVED FROM THE FIELD. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) EXPEDIUM SI POLY-DRIVER ASSY. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589536 ↗
• MalfunctionFeb 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POSTERIOR SPINAL FUSION SURGERY A LARGE PATIENT WITH HARD BONE REQUIRED A GREAT DEAL OF TORQUE ON INSTRUMENTATION. TIPS OF THREE INSTRUMENTS BROKE DURING A CASE WITH A PATIENT. THERE WAS A SURGICAL DELAY OF LESS THAN ONE (1) MINUTE. FRAGMENTS WERE GENERATED AND EASILY REMOVED. PATIENT STATUS IS UNKNOWN. REPLACEMENT INSTRUMENTS IMMEDIATELY AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT PRODUCT REPORTED: MOD 5.5 TAP, MOD CURVED PROBE, EXPEDIUM SI POLY-DRIVER ASSY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) EXPEDIUM SI POLY-DRIVER ASSY. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301206 ↗
• InjuryJan 6, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) CUSTOM SHORT HAND EXPEDIUM SINGLE INNIE POLY DRIVER AND ONE (1) REGULAR EXPEDIUM DRIVER BROKE INTRAOPERATIVELY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 20 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT HARM/CONSEQUENCE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9554438 ↗
• InjuryJan 6, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) CUSTOM SHORT HAND EXPEDIUM SINGLE INNIE POLY DRIVER AND ONE (1) REGULAR EXPEDIUM DRIVER BROKE INTRAOPERATIVELY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 20 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT HARM/CONSEQUENCE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9554418 ↗
• InjuryJan 6, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) CUSTOM SHORT HAND EXPEDIUM SINGLE INNIE POLY DRIVER AND ONE (1) REGULAR EXPEDIUM DRIVER BROKE INTRAOPERATIVELY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 20 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT HARM/CONSEQUENCE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9554141 ↗
• InjuryJan 6, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) CUSTOM SHORT HAND EXPEDIUM SINGLE INNIE POLY DRIVER AND ONE (1) REGULAR EXPEDIUM DRIVER BROKE INTRAOPERATIVELY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 20 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT HARM/CONSEQUENCE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9554046 ↗