NA 219958Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705007011), received between Apr 7, 2017 and May 3, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 30MM MODULAR DRIVER - BIOCOMPOSITE DEVICE WAS STRIPPED WHEN THE TIBIA WAS BEING FIXATED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL PART WAS DEFORMED. 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 16863222 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN ITALY THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP ON THE 30MM MODULAR DRIVER - BIOCOMPOSITE DEVICE WAS BROKEN. ACCORDING TO THE REPORT, THE DEVICE SEEMED TO BE WORN. 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 15186866 ↗
• MalfunctionOct 15, 2020Inaccurate Information; Inaccurate Information

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A KNEE ARTHROSCOPY IT WAS NOTED THAT A 30MM MODULAR DRIVER - BIOCOMPOSITE HAD A WRONG DESCRIPTION LASERED. IT IS WRITTEN 2,5MM INSTEAD OF 30MM. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED A SURGICAL DELAY DID NOT OCCUR AND THE CASE WAS COMPLETED WITH THE SAME DEVICE AS AN ALTERNATIVE WAS NOT AVAILABLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

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

  MAUDE report 10684805 ↗
• 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 9555746 ↗
• 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 30 MM 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 9555727 ↗
• 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 30 MM 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 9555718 ↗
• 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 9554354 ↗
• MalfunctionDec 20, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THEIR 30 MM MODULAR DRIVER BROKE OFF IN THE SCREW. IT WAS REPORTED THAT THE TIP WAS REMOVED FROM THE SCREW WITH NO FURTHER ISSUE AND NO DEBRIS WAS LEFT IN THE PATIENT. FURTHERMORE, DURING THE SAME CASE, IT WAS FOUND THAT THE TIP OF THEIR 35 MM MODULAR DRIVER WAS BENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE 35 MM DRIVER WITH NO PATIENT HARM BUT THERE WAS A THREE MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE OVER FIVE YEARS OLD AND HAVE SEEN HEAVY USE IN THE FIELD. THERE WAS A 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: Not Applicable

  MAUDE report 9504703 ↗
• MalfunctionSep 23, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE CUSTOMER'S 30 MM MODULAR DRIVER-BIOCOMPOSITE IS TWISTED AND BENT AT THE TIP OF THE DEVICE WHERE IT ACCEPTS THE SCREW. THE SALES REP STATED THAT THIS WAS LIKELY CAUSED FROM TORQUE PLACED ON THE DEVICE DURING PROCEDURES. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAYS. THE SALES REP WAS UNABLE TO PROVIDE A LOT NUMBER. 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 9103928 ↗
• MalfunctionOct 4, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE CUSTOMER'S 30MM MODULAR DRIVER TIP BROKE OFF DURING SCREW INSERTION. THE SALES REP STATED THERE WERE NO FRAGMENTS LEFT IN THE PATIENT, AND THE PATIENT DID NOT HAVE ANY ABNORMAL BONE DENSITY. THE SALES REP STATED THE DEVICE HAS SEEN HEAVY USE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICE IS BEING RETURNED FOR EVALUATION. 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 7934630 ↗
• MalfunctionApr 7, 2017Break; Break

  THE AFFILIATE REPORTED VIA EMAIL THE DEVICE BROKE AT THE FINAL TIGHTENING OF THE SCREW. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON (B)(6) 2017 THERE WAS NO HARM TO THE PATIENT, HE DID NOT NEED TO BE HOSPITALIZED, HE DID NOT NEED ANOTHER SURGICAL PROCEDURE, HE DID NOT HAVE ANY OTHER SERIOUS DAMAGE AND THE METAL PART OF THE BROKEN KEY WAS REMOVED WITHOUT INTERCURRENCES. THE PIECE BROKE AND STAYED INSIDE THE SCREW, THE SURGEON WAS ABLE TO REMOVE THE PIECE WITH A STRONG TWEEZERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6473468 ↗