NA 314.463Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886982188878), received between Dec 21, 2016 and Jan 30, 2026 — classified as 3 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Break” (49 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223755 ↗
• MalfunctionJan 22, 2026Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2026, THAT THE TIP IS DEFORMED. ISSUE WAS NOTICED PROBLEM ON (B)(6) 2025, DURING SURGERY. NO INJURIES TO PATIENT OR STAFF. NO DELAYS TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151335 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE A 2.0MM DRILL BIT BROKE WHILE DRILLING. A SMALL FRAGMENT OF THIS WAS LEFT INSIDE THE PATIENT'S BONE SINCE IT COULD NOT BE REMOVED DUE TO DIFFICULT EXTRACTION. THEN ANOTHER BIT OF THE SAME DIAMETER AND CHARACTERISTICS WAS USED. IN ADDITION TO THIS WHEN PLACING THE SCREWS A 3.0MM SCREWDRIVER BROKE. ANOTHER SCREWDRIVER FROM THE STOCK WAS THEN USED WITHOUT PROBLEM BECAUSE THE SCREWS TO BE PLACED WERE SELF-DRILLING. THUS ACHIEVING SUCCESSFUL COMPLETION OF THE SURGERY, AND WITHOUT ALTERATIONS IN SURGICAL TIMES. DURING AND AFTER THE SURGERY THE PATIENT'S CONDITION WAS STABLE AND WITHOUT ANY ADDITIONAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777917 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THE TIP HAS SNAPPED OFF. THE PRODUCT DAMAGE DOCUMENTED HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737010 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER SNAPPED DURING PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 21232330 ↗
• MalfunctionJan 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW DRIVER STRIPPED. THERE WAS PATIENT NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067985 ↗
• MalfunctionDec 9, 2024Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 25, 2024, THE SCREWDRIVER CRUCIFORM WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881189 ↗
• MalfunctionJul 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE TIP OF THE SCREWDRIVER WAS DAMAGED. ANOTHER SCREWDRIVER WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829142 ↗
• MalfunctionMay 16, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE A CANNULATED CRUCIFORM SCREWDRIVER BROKE. FRAGMENT WAS GENERATED AND IT WAS TOO SMALL TO BE TAKEN OUT FROM THE PATIENT. THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) CANNULATED CRUCIFORM SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19335162 ↗
• MalfunctionApr 17, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY THERE WAS A BROKEN KEY. THE BROKEN KEY LED TO THE NEED TO OPEN A NEW BOX OF DIFFERENT SCREWS IN DIAMETER FROM WHAT WAS INITIALLY PLANNED. THIS SITUATION, HAD NO DIRECT IMPACT ON THE FINAL RESULT, BECAUSE IT WAS CONTEMPLATED THAT THEY COULD BE USED, BUT THE NEED AROSE BECAUSE THE KEY WAS BROKEN. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128110 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HANDLES ARE FALLING APART. THE EVENT OCCURRED DURING STERILE PROCESSING, CALIBRATION AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054384 ↗
• MalfunctionNov 8, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE IS BROKEN. THERE WAS NO IMPACT TO THE SURGERY. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18094596 ↗
• MalfunctionAug 8, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER APPEARS TO BE DEFECTIVE IN THE SET, ONE (1) OF THE FOUR (4) 4 PINS HAS BROKEN OFF. IT IS INDICATED THAT THEY SHOULD START WORKING WITH THIS SCREWDRIVER, AS THIS IS ALL THEY HAVE. THERE IS A RISK THAT THE SCREWDRIVERS WILL COMPLETELY FAIL DURING TODAY'S OPERATION. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480640 ↗
• InjuryJun 8, 2023Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY WITH 3.0MM CANNULATED SCREWS. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023, AND ONE OF THE TWO SCREWS COULD NOT BE REMOVED. THE SURGEON CHECKED THE SCREWDRIVER SHAFT AND FOUND THAT THE TIP OF THE SCREWDRIVER HAD BEEN DAMAGED. THEREFORE, THE INCISION WAS CLOSED WITH THE SCREW REMAINING IN PLACE. IT IS UNCLEAR WHEN THE BREAKAGE OF THE SCREWDRIVER OCCURRED. IT HAS NOT BEEN CONFIRMED BY X-RAY, BUT IT IS POSSIBLE THAT IT REMAINS IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF MORE THAN 30 MINUTES. THIS REPORT INVOLVES ONE 3.0MM TI CANNULATED SCREW SHORT THREAD/30MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17088736 ↗
• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) B2022, A SCREWDRIVER BROKE. PATIENT AND PROCEDURE INVOLVEMENT IS UNKNOWN. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR ONE CANNULATED CRUCIFORM SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183361 ↗
• MalfunctionOct 28, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY THE CONSULTANT NOTICED THAT THE SCREW DRIVER TIPS ARE DAMAGED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694029 ↗
• MalfunctionOct 28, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY THE CONSULTANT NOTICED THAT THE SCREW DRIVER TIPS ARE DAMAGED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693282 ↗
• MalfunctionJun 16, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS CONFIRMED AT THE AGENCY BEFORE IT REACHED THE HOSPITAL THAT PART OF THE CANNULATED CRUCIFORM SCREWDRIVER IN QUESTION WAS CHIPPED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714479 ↗
• MalfunctionMay 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 SCREWDRIVER BROKE. NO PATIENT IMPACT. SURGERY DELAYED DUE TO THE REPORTED EVENT WAS UNKNOWN. PROCEDURE SUCCESSFULLY COMPLETED WAS UNKNOWN. THERE WAS NO ADVERSE CONSEQUENCES. OTHER MEDICAL INTERVENTIONS REQUIRED WAS ALSO UNKNOWN. THERE WAS A PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399933 ↗
• MalfunctionJan 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY FOR THE DISTAL TIBIA WITH A SCREWDRIVER. AT THE TIME OF REMOVAL, THE TIP OF THE SCREWDRIVER WAS BROKEN, RESULTING IN DIFFICULTY IN REMOVAL. THE SURGERY WAS COMPLETED. THERE WAS A THIRTY (30) MINUTE SURGICAL DELAY. AN X-RAY CONFIRMED THAT NO FRAGMENTS WERE RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306669 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A FIELD INVENTORY, THE SCREW DRIVER TIP IS BROKEN AND TWO (2) OF THE FOUR (4) SCREWS HAVE BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12617556 ↗
• MalfunctionSep 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE CANNULATED CRUCIFORM SCREWDRIVER WAS STRIPPED UPON INSERTION OF THE CANNULATED SCREW HEAD. THERE WERE FIVE MINUTES SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541581 ↗
• MalfunctionSep 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE SCREWDRIVER SEEMS TO BE STRIPPED AND DOESNT WORK. IT WAS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1)CANNULATED CRUCIFORM SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482169 ↗
• MalfunctionAug 18, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR THE CANNULATED CANCELLOUS SCREW REMOVAL SURGERY FOR THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING THE SURGERY, THE SCREWDRIVER TIP WAS MISSING AND UNABLE TO REMOVE THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339677 ↗
• MalfunctionAug 2, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PART OF THE SCREWDRIVER IS BROKEN OFF. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) CANNULATED CRUCIFORM SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259461 ↗