NA 254847Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705027699), received between Nov 25, 2019 and Jan 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, THE ASMBLY, RATCHET HANDLE, QUICK DISCONNECT DEVICE COMPONENT FELL OFF AND WAS UNUSABLE. IT WAS REPORTED THAT THE SURGEON CHANGED ANOTHER ASMBLY, RATCHET HANDLE, QUICK DISCONNECT DEVICE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173597 ↗
• MalfunctionJun 30, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE THE TWO (X2) RATCHET HANDLE DEVICES WERE BEING USED WHEN THE SCRUB TECH FOR THE CASE, SHE WENT TO CONNECT THE QUICK CONNECT HANDLE TO THE DRIVER AND THE HANDLE FELL APART. WE ATTEMPTED TO PUT IT BACK TOGETHER BUT IT DID NOT WORK. THEY GRABBED THEIR BACKUP HANDLE THAT IS PEEL PACKED AND THE SAME ISSUE OCCURRED. THIS FORCED US TO HAVE TO OPEN ANOTHER BTB TRAY THAT WE HAVE AT THIS ACCOUNT TO GET A PROPERLY WORKING HANDLE. THERE WAS A 15 MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356841 ↗
• MalfunctionJun 30, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE THE TWO (X2) RATCHET HANDLE DEVICES WERE BEING USED WHEN THE SCRUB TECH FOR THE CASE, SHE WENT TO CONNECT THE QUICK CONNECT HANDLE TO THE DRIVER AND THE HANDLE FELL APART. WE ATTEMPTED TO PUT IT BACK TOGETHER BUT IT DID NOT WORK. THEY GRABBED THEIR BACKUP HANDLE THAT IS PEEL PACKED AND THE SAME ISSUE OCCURRED. THIS FORCED US TO HAVE TO OPEN ANOTHER BTB TRAY THAT WE HAVE AT THIS ACCOUNT TO GET A PROPERLY WORKING HANDLE. THERE WAS A 15 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 PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356680 ↗
• MalfunctionJan 30, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A SURGICAL PROCEDURE OF THE FOOT PERFORMED ON (B)(6) 2023 IT WAS OBSERVED THAT THE RATCHET HANDLE DEVICE WAS BROKEN. IT WAS REPORTED THAT THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT TO CHANGE TO ANOTHER SCREWDRIVER DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE COLLAR IS UNATTACHED FROM ITS RETAINING RING. THE COLLAR WAS THREADED AGAIN TO VERIFY ANY SIGNS OF A DAMAGE ON THE THREADS, THE COLLAR WAS ABLE TO BE REATTACHED. THE REVERSE CAP WAS FOUND TO BE LOOSE DUE TO THE LOCKING MECHANISM RING WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608707 ↗
• MalfunctionMar 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT AT THE END OF AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON (B)(6) 2023, IT WAS OBSERVED THAT THE MECHANISM OF THE NEW RATCHET HANDLE DEVICE FELL APART WHEN THE SURGEON DISENGAGED THE 23 MM DRIVER FROM THE 2ND MILAGRO SCREW IMPLANTED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS THAN FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584645 ↗
• MalfunctionAug 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE PART OF THE HANDLE ON THE RATCHET HANDLE DEVICE THAT TOOK THE DRIVER PORTION FELL OFF WHILE SCREWING IN AN IMPLANT. 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 12282258 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE RATCHET HANDLE DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COLLAR TRI-LOBE PUSHER COMPONENT WAS DETACHED AND SEPARATED FROM THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A FIVE MINUTE DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147035 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S RATCHET HANDLE QUICK CONNECT PULLED STRAIGHT OFF THE DEVICE. THE SALES REP STATED THAT THIS OCCURRED WHILE THE DEVICE WAS BEING LOADED AND HAPPENED PRIOR TO USE ON THE PATIENT. THE CASE WAS COMPLETED WITH A HEX DRIVER WITH NO PATIENT HARM, BUT A TWO MINUTE DELAY TO OBTAIN THE NEW DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TRI-LOBE COLLAR WAS RECEIVED DETACHED FROM THE REST OF THE HANDLE AND THE RETAINING CAP HAD BEEN UNSCREWED FROM THE COLLAR. 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 9370676 ↗