NA 698341353Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034473703), received between Nov 26, 2019 and Dec 26, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TORQUE SHAFTS X2 & SCREWDRIVER SHAFTS X2 ALL STRIPPED DURING OUR REVISION CASE. OPENED PEEL PACKS. FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1)MOD SQUARE EXP 5.5 SI DRIVER THIS IS REPORT 4 OF 4 FOR COMPLAINT X25 FINAL TIGHTENER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394365 ↗
• MalfunctionDec 26, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TORQUE SHAFTS X2 & SCREWDRIVER SHAFTS X2 ALL STRIPPED DURING OUR REVISION CASE. OPENED PEEL PACKS. FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1)MOD SQUARE EXP 5.5 SI DRIVER THIS IS REPORT 2 OF 4 FOR COMPLAINT X25 FINAL TIGHTENER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394353 ↗
• MalfunctionSep 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, INSTRUMENTS WERE WORN DOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) MOD SQUARE EXP 5.5 SI DRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775711 ↗
• MalfunctionJul 20, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SRT EXPEDIUM 5.5 DRIVER TIP WAS FOUND BROKEN. DURING THE SCREW INSERTION INTO VERY HARD BONE THEN SECOND DRIVER STRIPPED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) MODIFIED INSTRUMENT SCREWDRIVER 5.5MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367590 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SRT EXPEDIUM 5.5 DRIVER TIP WAS FOUND BROKEN. DURING THE SCREW INSERTION INTO VERY HARD BONE THEN SECOND DRIVER STRIPPED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) MODIFIED INSTRUMENT SCREWDRIVER 5.5MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367443 ↗
• MalfunctionJun 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN DOWN. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MOD SQUARE EXP 5.5 SI DRIVER THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078289 ↗
• MalfunctionJun 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN DOWN. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MOD SQUARE EXP 5.5 SI DRIVER. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078288 ↗
• MalfunctionJun 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN DOWN. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MOD SQUARE EXP 5.5 SI DRIVER. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078286 ↗
• MalfunctionDec 8, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE SCREWDRIVER WAS WORN DOWN. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MODIFIED INSTRUMENT SCREWDRIVER 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15943783 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE EXPEDIUM DRIVER WAS BROKEN. SURGICAL DELAY IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) MOD SQUARE EXP 5.5 SI DRIVER. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193776 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE EXPEDIUM DRIVER WAS BROKEN. SURGICAL DELAY IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) MOD SQUARE EXP 5.5 SI DRIVER. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193771 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT THE REVISION PROCEDURE WAS PERFORMED TO EXTEND UP A LEVEL DUE TO DEGENERATIVE CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694212 ↗
• MalfunctionDec 11, 2020Break; Break

  IT WAS REPORTED THAT DURING POSTERIOR SPINAL FUSION SURGERY ON (B)(6) 2020, WHILE THE SURGEON WAS PLACING THE SCREW IN THE L2 PEDICLE, THE TIP OF THE CUSTOM-MADE SCREWDRIVER FOR THE POWER EASE BROKE OFF IN THE SCREW. THE TIP OF THE SCREWDRIVER REMAINED IN THE SCREW. THE SCREW AND DRIVER FRAGMENT WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A MOD SQUARE EXP 5.5 SI DRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991723 ↗
• MalfunctionMar 27, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOM MADE EXPEDIUM POWEREASE DRIVER TIP STRIPPED OUT DURING SCREW INSERTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9888204 ↗
• MalfunctionNov 26, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE EXPEDIUM POWEREASE CUSTOM DRIVER T20 TIP IS BROKEN. IT WAS UNKNOWN HOW THE ISSUE DISCOVERED. THERE WAS NO PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375830 ↗