MULTILOC 03.019.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10886982069641), received between Dec 22, 2016 and May 20, 2026 — classified as 3 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Detachment of Device or Device Component

  AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT ONE OF THE INSTRUMENTS WAS DAMAGED. THIS ITEM IS A SCREWDRIVER FOR THE MULTILOC HUMERAL NAIL SET. THIS SCREWDRIVER HAS AN INSERT THAT GOES INTO THE SCREWDRIVER AND THIS INSERT HAS A CAP AND THAT CAP HAS COME OFF AND WILL NOT STAY ON. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THERE WAS N PATIENT INVOLVEMENT. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232456 ↗
• MalfunctionDec 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A BROKEN PART. THE CAP FELL OFF THE SCREW DRIVER ROD. THE UNIT WAS IN TRAY. THE TRAY WAS ON A CASE. WHEN THE TRAY WAS RETURNED TO THE FSN, IT WAS NOTED THAT THE ITEM WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898188 ↗
• MalfunctionDec 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE INSTRUMENT ENTERED THE HOSPITAL WITH A CERTIFICATE OF WASHING AND DECONTAMINATION, BUT STILL CONTAINED TRACES OF BLOOD INSIDE. THE KEY HAS 2 PARTS AND WAS NOT PROPERLY DISASSEMBLED AND WASHED. IT WAS USED IN SURGERY WITH DRIED BLOOD FROM ANOTHER INSTITUTION. ACTION TAKEN WAS NEW EMERGING WASHING AND STERILIZATION METHODS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770516 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE CAP OF THE SCREWDRIVER HANDLE BROKE OFF THE HANDLE AND DID NOT ALLOW TO EFFECTIVELY REMOVE THE SCREWDRIVER. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574761 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SCREWDRIVER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534265 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025, THE SCREWDRIVER WAS BROKEN. ALL FRAGMENTS WERE REMOVED. ANOTHER INSTRUMENT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIFTEEN MINUTES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978172 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE KNOB FOR SELF RETENTION PIN PULLED OFF DURING SURGERY. NO DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496558 ↗
• MalfunctionJun 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BACKSIDE OF THE PART WAS DECONTAMINATED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301915 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWDRIVER. AFTER INSERTING THE MULTILOC HUMERAL NAIL SCREW, THE SCREWDRIVER GOT BROKEN WHEN THE SURGEON TRIED TO PULL OUT THE INNER SHAFT OF THE SCREWDRIVER. THE SURGEON PULLED THEM WITH THE PLIERS AND A HAMMER, THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174504 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR HUMERUS SHAFT FRACTURE WITH THE GUIDEWIRE (POLO) AND THE SCREWDRIVER. A MULTILOCK WAS USED FOR THE HUMERUS SHAFT FRACTURE. THE PROCEDURE WAS NORMAL. AFTER INSERTING THE NAIL, THE SURGEON FORGOT TO REMOVE THE GUIDEWIRE AND A MULTILOCK SCREW WAS INSERTED. AFTER INSERTING THE SCREW, IT WAS CONFIRMED THAT THE GUIDEWIRE HAD BEEN FORGOTTEN TO BE REMOVED. THE SCREW WAS REMOVED, AND THE GUIDEWIRE WAS REMOVED. THE SCREW WAS THEN REINSERTED. IN ADDITION, WHEN INSERTING THE MULTILOCK SCREW, ASSEMBLED THE SCREWDRIVER WITH INNER SHAFT AS INSTRUCTED IN THE PROCEDURE MANUAL, THE INNER SHAFT WAS INSERTED, AND THE SCREW WAS INSERTED. WHEN THE SCREWDRIVER WAS ATTEMPTED TO BE REMOVED, THE CIRCULAR PART OF THE INNER SHAFT CAME OFF. ONLY THE ROD-SHAPED PART OF THE INNER SHAFT WAS LEFT IN THE SCREWDRIVER, SO IT WAS GRASPED WITH PLIERS OR A VICE CLIP AND REMOVED BY HITTING IT WITH A HAMMER. AS THE CIRCULAR PART CAME OFF WITH THE FIRST MULTILOCK SCREW, THE SECOND AND THIRD SCREWS WERE INSERTED WITHOUT A LOCKING MECHANISM AND USING ONLY THE SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 120 MINUTES OF DELAY. THE PATIENT OUTCOME WAS REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139930 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE INSTRUMENT WAS BROKEN. THE SURGERY WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548886 ↗
• MalfunctionFeb 26, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PRODUCT WAS DAMAGED, DOESN'T CAPTURE ONTO SCREW HEADS. THE PATIENT CONSEQUENCES WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21470274 ↗
• MalfunctionFeb 7, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT OUTCOME WAS EVERYTHING CAME OUT FINE AS STATED. NO ALLEGATIONS AGAINST SCREWS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337868 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER END HAS BROKEN OFF. THIS WAS FOUND DURING RE-PROCESSING OF THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242860 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT THE MULTILOC SCREWDRIVER IS BROKEN. THE END CAP OF THE INNER ROD HAS FALLEN OFF.

  Patient problems: Insufficient Information

  MAUDE report 20800558 ↗
• MalfunctionOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON SEPTEMBER 1, 2024, THE END PART OF THE DEVICE LOOSENED AND FELL OFF DURING SURGERY. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20439176 ↗
• MalfunctionOct 4, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 WHILE INSPECTING TRAYS IN METRO, IT WAS NOTICED THAT THE ITEMS IN QUESTION WERE DAMAGED. THE PROCEDURE AND PATIENT OUTCOME ARE NOT KNOWN. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871271 ↗
• MalfunctionJun 1, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE HEAD OF THE INNER PART OF THE SCREWDRIVER FOR MULTILOCK SCREWS FELT OFF. THERE WAS NO SURGICAL DELAY, AND NO PATIENT INVOLVEMENT. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE BASE OF THE DEVICE WAS BROKEN. THIS REPORT INVOLVES ONE SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039313 ↗
• MalfunctionMay 5, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT SURGERY FOR THE HUMERUS WITH THE MULTILOC SCREW. WHEN THE SURGEON ATTACHED THE MULTILOC SCREW TO THE SCREWDRIVER, THE REARMOST OF THE INSTRUMENT¿S COMPONENTS CAME OFF. AFTER THAT, THE SURGEON MADE SEVERAL ATTEMPTS TO ATTACH IT, BUT COULD NOT SOLVE THE PROBLEM. FINALLY, THE SURGEON INSERTED THE MULTILOC SCREW WITHOUT HOLDING IT BY THE SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. THERE WAS NO PROBLEM WITH BONE FIXATION, AND THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876019 ↗
• MalfunctionMar 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN UNITED ARAB EMIRATES AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE NEWLY CONSIGNMENT SUPPLIED MULTILOC SCREWDRIVER (03.019.025) IS STRONGLY ATTACHED TO MULTILOC SCREWS EVEN WITHOUT INSERTION OF THE RETENTION PIN. WHEN THE SURGEON TRIES TO PULL OUT THE SCREWDRIVER AFTER INSERTING THE SCREW, & AFTER REMOVING THE RETENTION PIN, THE SCREW PULLS OUT FROM THE BONE WITH THE DRIVER, DUE TO STRONG ATTACHMENT BETWEEN THE SCREW & THE TIP OF THE SCREWDRIVER. INCIDENT HAPPENED 3 TIMES WITHIN THE SAME SURGERY. SURGEON HAD TO PUSH THE SCREW INSIDE MANUALLY WITHOUT USING THE SCREWDRIVER. IT WAS THE FIRST CASE WITH THIS NEW CONSIGNMENT SET. THE SURGERY WAS FOR 30 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT OUTCOME/CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) SCRDRIVER F/MULTILOC SCR Ø4.5 W/SELFHOLD THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555169 ↗
• MalfunctionJun 30, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE HEAD OF THE SILVER PIECE POPPED OFF WHEN TRYING TO DISENGAGE THE DRIVER FROM A SCREW. NEED A REPLACEMENT. THE PART IS AVAILABLE TO SEND BACK. CONCOMITANT DEVICE REPORTED: UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS COMPLAINT INVOLVES ONE(1) DEVICE SCRWDRVR 4.5 TI MULTILC SCRS/SLF-RET/330. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877883 ↗
• MalfunctionMar 11, 2022Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE SCREWDRIVER FOR THE FRACTURE OF THE PROXIMAL HUMERUS. AFTER INSERTING THE NAIL, THE KNOB AT THE BASE OF THE SCREWDRIVER CAME OFF WHEN THE SURGEON TRIED TO INSERT THE SCREW. AFTER INSERTING THE SCREW TO THE OPTIMAL POSITION, THE SURGEON USED PLIERS TO REMOVE THE SCREWDRIVER. TWO MORE SCREWS WERE INSERTED WITH THE BROKEN SCREWDRIVER. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732278 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER FOR 4.5 MM TITANIUM MULTILOC SCREW, SELF-RETAINING, 330MM WAS FOUND BROKEN UPON INSTRUMENT INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES (1) SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804783 ↗
• MalfunctionAug 17, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, PART OF THE SCREWDRIVER¿S METAL HANDLE CAME OFF COMPLETELY. THERE WAS NO HARM DONE HOWEVER, SCREWS COULD NOT BE SECURED APPROPRIATELY TO THE SCREWDRIVER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A SCREWDRIVER FOR 4.5MM TITANIUM (TI) MULTILOC SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331586 ↗
• MalfunctionApr 14, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666004 ↗