NA 03.100.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886982070814), received between Nov 27, 2018 and Apr 23, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT THE DEVICE BROKE/DAMAGED DURING A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972378 ↗
• MalfunctionJan 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THE HANDLE OF THE SCREWDRIVER ATTACHMENT WAS LOOSE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960053 ↗
• MalfunctionJul 9, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT RATCHETING SCREWDRIVER IS VERY LOOSE AND NEEDS TO BE REPLACED. TORQUE LIMITER NO LONGER ATTACHES TO AO REAMING COUPLER. NO PATIENT INVOLVEMENT WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22464269 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT (SPD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952089 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT RATCHET WAS BROKEN ON DEVICES. NO OPERATION WAS INVOLVED. THERE WAS NO PATIENT INVOLVEMENT AND THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405089 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT RATCHET WAS BROKEN ON DEVICES. NO OPERATION WAS INVOLVED. THERE WAS NO PATIENT INVOLVEMENT AND THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402612 ↗
• MalfunctionJan 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE TRAY.

  Patient problems: Insufficient Information

  MAUDE report 21246492 ↗
• MalfunctionOct 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE OF MALFUNCTION. A T8 SCREW DRIVER BIT WAS STUCK INSIDE RATCHET SCREWDRIVER HANDLE. NO DOCTOR OR SPECIFIC SURGERY WAS INVOLVED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510747 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AUG 22, 2024 THE RATCHETING HANDLE WILL NO LONGER HOLD A SCREWDRIVER SHAFT IN THE COUPLING PORTION OF THE HANDLE. THEN THE COMPRESSION DEVICE LATCH WILL NOT STAY LOCKED AND IS LOOSE. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING, FIELD INSPECTION OR CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189448 ↗
• MalfunctionSep 5, 2024Break; Break

  NO PATIENTS WERE AFFECTED. THE TWO RATCHET SCREWDRIVERS ARE NOT WORKING CORRECTLY ACCORDING TO THE SURGEON, IT WAS REPLACED WITH A DIFFERENT DRIVER DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153148 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE BROKEN RATCHET SCREWDRIVERS NEEDS TO BE REPLACE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) OF THREE (3) RATCHETING HANDLE WITH QUICK COUPLING FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153143 ↗
• MalfunctionMay 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A PELVIC FRACTURE. THE PRODUCTS IN QUESTION DID NOT ROTATE PROPERLY DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. WHEN THE PRODUCTS WERE CHECKED AGAIN AFTER THE SURGERY, THE SAME DEFECTIVE CONDITION AS DURING THE SURGERY WAS CONFIRMED. WHEN PRODUCTS OTHER THAN THE PRODUCTS IN QUESTION WERE ATTACHED TO THE POWER TOOL, IT WAS CONFIRMED THAT THE OTHER PRODUCTS ROTATED NORMALLY. THE SURGERY WAS COMPLETED USING AN ALTERNATIVE PRODUCT. THIS REPORT IS FOR ONE (1) 3.5MM SCREWDRIVER SHAFT HEXAGONAL-LONG. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19420401 ↗
• MalfunctionMay 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON APRIL 17, 2024 DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN, IT WAS IDENTIFIED THAT THE TWO INSTRUMENTS ARE STUCK TOGETHER AND UNABLE TO BE TAKEN APART. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) RATCHETING HANDLE WITH QUICK COUPLING THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323843 ↗
• MalfunctionJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER SHAFT WAS STUCK IN A RATCHETING HANDLE. THERE WERE NO PATIENT CONSEQUENCES. TIMING OF THE EVENT WAS POSTOPERATIVE. THIS REPORT INVOLVES ONE RATCHETING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134394 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING POST-OP IT WAS NOTICED THAT THE WRIST FUSION GRAPHIC CASE WAS DROPPED AND THE HINGE BROKE OFF. IMPLANT CASE WAS ALSO BROKEN. BOTH WERE DISCARDED. RATCHETING DRIVER INSIDE SET DOES NOT ¿RATCHET¿ OR SPIN. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES (1) DEVICES. THIS REPORT IS FOR (1) RATCHETING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541648 ↗
• MalfunctionMay 20, 2022Break; Break

  STERILE PROCESSING DEPARTMENT (SPD) ALERTED JNJ EMPLOYEE OF BROKEN INSTRUMENT AFTER COMING THROUGH THE WASH. THIS REPORT IS FOR A RATCHETING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454394 ↗
• MalfunctionMay 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT THE QUICK COUPLING IS BROKEN. THIS COMPLAINT INVOLVES ONE (1) DEVICE RATCHETING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317924 ↗
• MalfunctionMay 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TEAM WAS SETTING UP FOR A PROCEDURE AND NOTICED THE INSTRUMENT WAS DAMAGED AND NOT FUNCTIONING. THE TEAM USED AN ALTERNATIVE SCREWDRIVER. NO DELAY TO SURGERY OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) RATCHET-HANDLE W/AO/ASIF-QC THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315943 ↗
• MalfunctionMay 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE QUICK COUPLING WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE RATCHETING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315344 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PRODUCTS FOUND BROKEN AFTER SURGERY AND ARE BEYOND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES. THIS REPORT IS FOR (1) RATCHETING HANDLE WITH QUICK COUPLING. THIS REPORT IS 7 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196426 ↗
• MalfunctionNov 3, 2021Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, PRE-OPERATIVELY IT WAS FOUND THAT THE RATCHETING HANDLE WITH QUICK COUPLING WAS BROKEN. IT WAS LOOSE AND NOT RATCHETING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) RATCHETING HANDLE WITH QUICK COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12747004 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A POSTOPERATIVE PROCEDURE. DURING THE PROCEDURE, THE QUICK COUPLING IS STICKING, AND THE RATCHET IS BROKEN ON THE SCREWDRIVER. IT WAS UNKNOWN IF THE PATIENT IMPACT IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) RATCHETING HANDLE WITH QUICK COUPLING. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416410 ↗
• MalfunctionJul 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE SURGEON WAS ATTEMPTING TO USE THE RATCHETING HANDLE WITH QUICK COUPLING TO REMOVE AND REPLACE THE UNKNOWN COMPRESSION SCREW WHILE THE RATCHET HANDLE WOULD NO LONGER RATCHET. SURGEON REQUESTED A SECOND PELVIC INSTRUMENT TRAY FOR THE SECOND RATCHET HANDLE WITH QUICK COUPLING WHICH WOULD ALSO NO LONGER RATCHET. SURGEON THEN PROCEEDED TO USE A SMALL HANDLE QUICK COUPLING SCREWDRIVER WITH THE POWER SHAFT TO REMOVE AND INSERT SCREWS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIVE(5) MINUTES SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) RATCHETING HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112179 ↗
• MalfunctionJul 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE SURGEON WAS ATTEMPTING TO USE THE RATCHETING HANDLE WITH QUICK COUPLING TO REMOVE AND REPLACE THE UNKNOWN COMPRESSION SCREW WHILE THE RATCHET HANDLE WOULD NO LONGER RATCHET. SURGEON REQUESTED A SECOND PELVIC INSTRUMENT TRAY FOR THE SECOND RATCHET HANDLE WITH QUICK COUPLING WHICH WOULD ALSO NO LONGER RATCHET. SURGEON THEN PROCEEDED TO USE A SMALL HANDLE QUICK COUPLING SCREWDRIVER WITH THE POWER SHAFT TO REMOVE AND INSERT SCREWS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIVE(5) MINUTES SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) RATCHETING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112178 ↗
• MalfunctionMay 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE NON-ACCEPTANCE OF THE INSTRUMENT WITH CABLE IN CELERON MATERIAL BY THE (B)(6) HOSPITAL MATERIALS CENTER, WE CONSULTED WITH NURSE (B)(6), RESPONSIBLE FOR THE TECHNICAL AREA OF THE HOSPITAL'S MATERIALS CENTER. IT IS A MATERIAL THAT HAS POROSITY DUE TO EXPOSURE TO THE TEMPERATURE OF THE STERILIZATION PROCESS. IT IS THE POROSITY OF THE CELERON THAT COMPROMISES THE CLEANING PROCESS. IT WAS UNDERSTOOD THEN THAT THE MATERIAL COMPROMISES THE STERILIZATION PROCESS, SINCE IT HAS POROSITY THAT DOES NOT GUARANTEE THE EFFECTIVENESS OF CLEANING. IF YOU ARE NOT IN ACCORDANCE WITH THE JUSTIFICATION PRESENTED, I SUGGEST THAT YOU PRESENT TO THE HOSPITAL TECHNICIANS RESPONSIBLE, A DOCUMENT WITH THE MANUFACTURER'S SPECIFICATIONS THAT MEET THE STANDARDS OF THE MANUALS OF GOOD CLEANING AND STERILIZATION PRACTICES. THIS REPORT IS FOR ONE (1) RATCHETING HANDLE WITH QUICK COUPLING. THIS IS REPORT 4 OF 15 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863394 ↗