NA 270127Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705014033), received between Mar 11, 2021 and Feb 20, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP OF THE HEX DRIVER WITH TEARDROP HANDLE 23MM DEVICE WAS BENT. THE DEVICE WAS NOT USED IN A PROCEDURE AS IT WAS FOUND WHILE CHECKING AN INSTRUMENT TRAY. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741720 ↗
• MalfunctionDec 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 23 MM HEX DRIVER WITH TEARDROP HANDLE WAS BENT UPON INSERTION AND 8X23MM MILAGRO ADVANCE INTERFERENCE SCREW WAS CRACKED AND REMOVED. THE BONE BLOCK SHEERED OFF THE GRAFT, IT IS UNCLEAR IF THE TWO THINGS ARE RELATED. THE GRAFT WAS REPREPPED TO CONVERT THE GRAFT TO ALL SOFT TISSUE AND USE A RIGID LOOP BUTTON IN THE FEMUR. THE TECH WAS ABLE TO BEND THE DRIVER TIP BACK BUT IT WAS OPTED TO USE THE 7X30 DRIVER TO PUT IN A 7X23 SCREW IN THE FEMORAL TUNNEL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TWENTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409262 ↗
• MalfunctionJan 11, 2023Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN THAT DURING AN UNKNOWN PROCEDURE OF THE KNEE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 23 MM HEX DRIVER WITH TEARDROP HANDLE 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 16138989 ↗
• MalfunctionApr 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP OF THE 23 MM HEX DRIVER WITH TEARDROP HANDLE WAS BENT AND NOT ALLOWING THE SCREW TO FIT ON THE TIP. ANOTHER LIKE DEVICE 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 14218907 ↗
• MalfunctionJan 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE 23MM HEX DRIVER W/TEARDROP HANDLE 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 13225932 ↗
• MalfunctionOct 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 23MM HEX DRIVER W/TEARDROP HANDLE WAS TORQUED AND 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 12625749 ↗
• MalfunctionMar 11, 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 TIP ON THE 23 MM HEX DRIVER WITH TEARDROP HANDLE WAS BENT AND COULD NOT GET THE SCREW IN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11465760 ↗