MULTILOC 03.019.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982069634), received between Sep 14, 2018 and Sep 11, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K103002, K120807); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE SURGEON REALIZED THAT THE NAIL WAS VERY SUNK IN THE MEDULLARY CHANNEL, SO HE MADE THE DECISION TO TAKE IT OUT A LITTLE. WHEN USING THE HAMMER OF THE EQUIPMENT, THE PIECE OF IMPACTOR WAS BROKEN, AT THE TIME OF TAKING IT AND CHECKING IT, IT WAS NOTED THAT THE PIECE BROKE, LEAVING THE REST IN THE FASTENING SCREW THE NAIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23027349 ↗
• MalfunctionDec 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SCREW THREADS OF EXTRACTION SCREW FOR MULTILOC HUMERAL NAIL SYSTEM WERE DAMAGED. THERE WAS NO CHANGE IN TECHNIQUE, NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913733 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT ON JUNE 27, 2024, DURING PREPARATION OF THE MULTILOC SIEVE, IT WAS NOTICED THAT TWO ITEMS WERE DAMAGED/BROKEN IN PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807293 ↗
• MalfunctionMay 2, 2023Device-Device Incompatibility; 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 SURGERY TO IMPLANT THE MULTILOC HUMERAL NAIL LONG FOR THE HUMERAL SHAFT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THEN, THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023 BECAUSE BONE UNION HAD BEEN ACHIEVED. IN THE REMOVAL SURGERY, THERE WAS DIFFICULTY IN REMOVING THE END CAP, DIFFICULTY IN CONNECTING THE EXTRACTION SCREW MULTILOC, AND DIFFICULTY REMOVING THE NAIL WITH THE CONNECTING SCREW FOR MULTILOC. ATTEMPTS WERE MADE TO REMOVE THE 15MM END CAP IN QUESTION, BUT THE POSITION OF THE END CAP WAS OVER INSERTED BY 10MM OR MORE. AS A RESULT, THE BONE GREW ON THE END CAP AND WAS DIFFICULT TO REMOVE. THE SURGEON USED A BONE CHISEL TO SCRAPE OFF BONE AND MANAGED TO EXTRACT THE END CAP, ADDING AN ADDITIONAL 45 MINUTES OF SURGICAL TIME. AFTER THAT, THE SURGEON TRIED TO CONNECT THE EXTRACTION SCREW FOR MULTILOC IN QUESTION, BUT THE DISK-SHAPED PART IN FRONT OF THE CONNECTION PART OF THE EXTRACTION SCREW BECAME A STOPPER, MAKING IT DIFFICULT TO CONNECT WITH THE NAIL. IF CONNECTION WAS CONTINUED, A LARGER HOLE HAD TO BE MADE IN ORDER TO CONNECT, BUT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852100 ↗
• MalfunctionApr 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR FRACTURE OF RIGHT HUMERAL SHAFT IN (B)(6), 2022. IN THE SURGERY, THE NAIL IN QUESTION WAS INTENTIONALLY IMPLANTED EXCESSIVELY TO PREVENT IMPINGEMENT, AND A 10 MM END CAP WAS USED. THE PROXIMAL PART OF THE NAIL WAS LOCKED WITH THE 2 SCREWS IN QUESTION, AND THE DISTAL PART WAS LOCKED WITH 3 LOCKING SCREWS. THE POSTOPERATIVE COURSE WAS GOOD, AND THE IMPLANTS USED IN THE INITIAL SURGERY WERE TO BE REMOVED ON (B)(6) 2023. IN THE REMOVAL SURGERY, OPERATIONS WERE PROCEEDED, AND THE ISSUES WERE OCCURRED AS FOLLOWS: AFTER REMOVING THE END CAP, THE SURGEON HAD A DIFFICULTY IN CONNECTING THE EXTRACTION SCREW TO THE NAIL BECAUSE THE DISK-SHAPED OVERHANG AROUND THE CONNECTION PART OF THE EXTRACTION SCREW INTERFERED WITH THE BONE AND SOFT TISSUE AROUND THE EXTRACTION SCREW. THE SURGEON ATTEMPTED TO EXTRACT THE 2 SCREWS IN QUESTION, BUT THE SURGEON HAD A DIFFICULTY IN EXTRACTING THEM DUE TO BONE INGROWTH AND THE DEFORMITY OF THE SCREW HEADS. THE 3 LOCKING SCREWS AT THE DISTAL PART OF THE NAIL WERE EXTRACTED SUCCESSFULLY WITH NO PROBLEM. EVENTUALLY, THE NAIL WAS SUCCEE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747026 ↗
• MalfunctionJun 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY USING THE MULTILOC NAIL FOR HUMERUS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE REMOVAL OF THE NAIL SURGERY WAS PERFORMED ON (B)(6) 2022, FOR UNKNOWN REASON WITH THE EXTRACTION SCREW. IN THE REMOVAL SURGERY, THE EXTRACTION SCREW DID NOT CONNECT WELL TO THE NAIL. THE SURGEON WAS ABLE TO SOMEHOW CONNECT THE EXTRACTION SCREW TO THE NAIL BY DIGGING QUITE A BIT THE SURROUNDINGS OF THE NAIL WITH A PAUL MYSEL CHISEL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 120 MINUTES DELAY. INITIALLY PLANNED SURGERY TIME WAS 60 MINUTES BUT ENDED UP TAKING 180 MINUTES. THE SURGEON CONSIDERED THAT THE SHAPE OF THE EXTRACTION SCREW HAD A NEGATIVE EFFECT BECAUSE THE OTHER COMPANY'S PRODUCT HAD NEVER HAD A TROUBLE AT REMOVAL LIKE THIS, ALTHOUGH THE NAIL HAD BEEN IMPLANTED SLIGHTLY DEEPER THAN USUAL. THE SURGEON MENTIONED THAT IT TAKES TIME TO REMOVE NAILS BECAUSE OF THE SHAPE OF EXTRACTION SCREW. THIS REPORT INVOLVES ONE (1) EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS PRODUCT C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632562 ↗
• MalfunctionMar 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT SURGERY FOR FRACTURE OF PROXIMAL END OF HUMERUS. AFTER SURGERY, ON (B)(6), 2022, THE REMOVAL SURGERY WAS PERFORMED DURING WHICH, HAD A LITTLE DIFFICULTY IN CONNECTING THE EXTRACTION SCREW TO THE NAIL BUT REMOVED THE NAIL NORMALLY IN THE END. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE REVISION SURGERY, WHEN THE SURGEON GAVE EXPLANATIONS TO THE PERSONS CONCERNED WITH THE PATIENT, IT WAS FOUND THAT A NEEDLE-LIKE WHITE SHADOW WAS REFLECTED IN THE X-RAY. THEREFORE, THE SURGEON CHECKED ALL THE MATERIALS USED IN THE OPERATION ROOM, INCLUDING NEEDLES, BUT DID NOT FIND ANY BROKEN ONES. WHEN THE REMOVED IMPLANTS WERE CHECKED, BREAKAGE WAS CONFIRMED AT THE THREADED PART OF THE NAIL THAT CONNECTS AN END CAP. THE SURGEON CHECKED THE X-RAY AFTER THE REMOVAL SURGERY BUT COULD NOT FIND ANYTHING LIKE NEEDLE-LIKE WHITE SHADOW AT THAT TIME. THE SURGEON COMMENTED AS FOLLOWS. WHEN THE EXTRACTION SCREW WAS CONNECTED TO THE NAIL, THE METAL CAME INTO CONTACT WITH EACH OTHER, AND THE LOAD ON THE THREADED PART CAUSED THE THREADED PART OF THE NAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653745 ↗
• MalfunctionMar 1, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE EXTRACTION SCREW HAD A WORN THREAD MAKING IT UNABLE TO EXTRACT THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: UNKNOWN HUMERAL NAIL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392973 ↗
• MalfunctionFeb 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 DURING AN UNKNOWN MEDICAL DEVICE REMOVAL THAT THE CONNECTION SCREW FOR REMOVAL OF MULTILOC NAIL DIDN¿T REALLY FIT IN THE THREAD, SO THEY HAD TO USE ANOTHER ONE FROM AN OTHER SYSTEM. THE SURGERY WAS PROLONGED BY 40 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9711488 ↗
• MalfunctionSep 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CUSTOMER HAD DIFFICULTY IN REMOVING A MULTILOC NAIL BECAUSE THE THREADS OF THE EXTRACTION SCREW USED TO EXTRACT THE NAIL ARE TOO SHORT AND DO NOT HOLD THE NAIL ENOUGH. A CONNECTION SCREW WAS USED IN ASSOCIATION TO THE EXTRACTION SCREW TO REMOVE THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY, BUT THE INSTRUCTIONS IN THE IFU WERE NOT FOLLOWED. A 20 MINUTES SURGICAL DELAY WAS REPORTED. THE PATIENT IS FINE AND REQUESTED THE REMOVAL OF THE NAIL, NO ISSUE WAS REPORTED FOR THE NAIL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877759 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103002, K120807. One submission often covers many models, so check the product and lot details in each record.

• Z-2059-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
• Z-2060-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu