NA 254641Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705013333), received between Jan 6, 2020 and Jan 9, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON USED A SAW BLADE DEVICE TO SHAVE DOWN A SCREW SO HE COULD GET A BIO-INTRAFIX MODHEXDRV 30MM NEEDLE DRIVER AROUND METAL PART THAT WAS BROKEN OFF INSIDE OF SCREW WHICH HAD BEEN IMPLANTED IN TIBIA. IT WAS REPORTED THAT THE SURGEON THEN MALLETED IT BACKWARD AND OUT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019191 ↗
• MalfunctionApr 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MODULAR HEX DRIVER 30 MM DEVICE WAS BENT AND BECAME INOPERABLE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818057 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT THE MODULAR HEX DRIVER 30 MM DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688343 ↗
• MalfunctionSep 8, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT THE MODULAR HEX DRIVER 30 MM DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380997 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE MODULAR HEX DRIVER 30 MM DEVICE BROKE OFF DURING SCREW INSERTION. THE DOCTOR WAS ABLE TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303561 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE MODULAR HEX DRIVER 30 MM BROKE OFF DURING SCREW INSERTION. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15301150 ↗
• MalfunctionJan 6, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE BIO-INTRAFIX MODHEXDRV 30MM DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178683 ↗
• MalfunctionAug 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BIO-INTRAFIX MODHEXDRV 30MM DEVICE WAS BENT AND DID NOT WORK PROPERLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293795 ↗
• MalfunctionMay 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT PRE-OPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BIO-INTRAFIX MODULDAR HEX DRIVE 30MM WAS BENT. THERE WAS NO SURGICAL DELAY NOR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862470 ↗
• MalfunctionApr 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MODULAR HEX DRIVER 30 MM DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753145 ↗
• MalfunctionJan 22, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR LIGAMENT RECONSTRUCTION PROCEDURE ON 1/7/2021, IT WAS OBSERVED THAT THE MODULAR HEX DRIVER 30 MM DEVICE GOT TWISTED AND BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214883 ↗
• MalfunctionJan 6, 2020Corroded; Corroded

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT RUST DEPOSITS WERE FOUND IN THE CANNULATION OF THE FOLLOWING DEVICES: 4 OF 30MM MODULAR DRIVER - BIOCOMPOSITE, 1 OF MODULAR HEX DRIVER, 23 MM, 1 OF MODULAR HEX DRIVER 30 MM, 1 OF RATCHET HANDLE W/JACOB'S CHK. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9555833 ↗