NA 219960Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705020249), received between Jan 22, 2019 and Apr 23, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE MODULAR DRIVER 23MM WAS BENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165626 ↗
• MalfunctionOct 12, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON (B)(4) 2023 .THE ASSEMBLY, 2.8MMX23MMX7.5" MODULAR DRIVER WAS BEING USED WHEN PLACING A MILAGRO SCREW. THE SCREW WAS ATTACHED TO MODULAR HEX DRIVER, 23 MM INTO THE PATIENT TO FIXATE THE FEMORAL SOCKET. THE DRIVER TIP THAT WAS ATTACHED TO THE SCREW BROKE OFF INTO THE SCREW AND INTO THE PATIENT. THE PHYSICIAN WAS UNABLE TO REMOVE THE METAL TIP AND SCREW OUT OF THE PATIENT, IT WAS LEFT IN SINCE SCREW HAD FULL FIXATED THE FEMORAL SOCKET. ANOTHER SET WAS USED TO COMPLETE THE CASE. THERE WAS A 20-30 MINUTE SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17919374 ↗
• MalfunctionJul 7, 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, 23 MM DEVICE WAS BENT. THE SAME 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 12129606 ↗
• 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 Patient Involvement

  MAUDE report 9554467 ↗
• MalfunctionSep 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S MODULAR HEX DRIVER HAD A BENT TIP. THE SALES REP DID NOT KNOW WHEN OR HOW THE TIP OF THE DEVICE BENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124812 ↗
• MalfunctionSep 18, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP ON THE CUSTOMER'S 23MM MODULAR HEX DRIVER WAS BENT WHEN REMOVING THE SCREW. IT WAS REPORTED THAT THE SCRUB TECH WAS ABLE TO BEND IT BACK TO NORMAL POSITION, BUT THE TIPS STRENGTH WAS COMPROMISED. NO PATIENT CONSEQUENCES AND ABOUT ONE MINUTE DELAY CAUSED. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THE SAME DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9081064 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL PROCEDURE, THE TIP OF THEIR ASSEMBLY 2.8MM X 23MM X 7.5" MODULAR DRIVER BROKEN WHEN REMOVING FROM THE TRAY. THE SALES REP CONFIRMED THAT THE DEVICE BROKE BEFORE USED ON THE PATIENT AND THAT NOTHING BROKE IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266512 ↗