MULTILOC 04.016.038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982089205), received between May 17, 2019 and Apr 8, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K103002); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED ON (B)(6) 2026 AROUND 11 AM REPORTER OPENED THE 9.5 MM RIGHT SIDE MULTILOC PROX HUMERUS NAIL. HOWEVER, REPORTER FOUND A LEFT SIDE NAIL PACKAGED IN THE BOX WITH RIGHT SIDE LABELED ON IT. PATIENT WAS NOT AFFECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS UNKNOWN WHETHER THE SURGERY DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817307 ↗
• MalfunctionDec 4, 2025Migration; Migration

  IT WAS REPORTED ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY WITH MHN SHORT 9.5MM FOR TREATING RIGHT PROXIMAL HUMERUS. THE SURGERY PROCEEDED ACCORDING TO THE STANDARD PROCEDURE, AND AFTER INSERTING THREE PROXIMAL MULTILOC SCREWS AND TWO DISTAL LOCKING SCREWS, IMAGE EVALUATION REVEALED THAT THE NAIL HEAD HAD PROTRUDED APPROXIMATELY 2 MM. IN ORDER TO RE-INSERT THE NAIL INTO THE BONE, ALL THE SCREWS WERE REMOVED, AND THE POSITION OF THE NAIL WAS CHECKED SEVERAL TIMES USING IMAGE, AND THE NAIL AND SCREWS WERE ABLE TO BE INSERTED IN THE CORRECT POSITION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 50 MINUTES OF DELAY. ACCORDING TO THE SURGEON, FOR THE INITIAL NAIL INSERTION, HE MADE SURE THE NAIL WAS NOT MISALIGNED, BUT THE PATIENT'S BONE QUALITY WAS POOR, AND THE MEDULLARY CAVITY WAS SO WIDE THAT THE NAIL COULD BE INSERTED WITHOUT RESISTANCE, THEREFORE IT WAS POSSIBLE THAT THE FORCE APPLIED WHEN INSERTING THE DISTAL LOCKING SCREWS CAUSED THE NAIL TO SHIFT POSITION. ANOTHER POSSIBILITY WAS THAT THERE MAY HAVE BEEN AN ERROR IN ASSESSING NAIL DEPTH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716778 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD HARDWARE REMOVAL DUE TO NON UNION, ONE (1) MULTILOC HUMERAL NAIL, ONE (1) MULTILOC SCREW LENGTH 50MM, ONE (1) MULTILOC SCREW LENGTH 42MM, ONE (1) MULTILOC SCREW LENGTH 48MM, ONE (1) MULTILOC SCREW LENGTH 40MM, ONE (1) TITANIUM LOCKING SCREW LENGTH 34MM, AND ONE (1) TITANIUM LOCKING SCREW LENGTH 36MM DUE TO SHOULDER PAIN AND LIMITED MOBILITY OF HUMERUS. THERE WERE FOUR PART PROXIMAL HUMERUS FRACTURE FIXED WITH THE NAIL BUT THE BONE HAD GONE ON TO DIE. THE SURGEON REMOVE ALL THE IMPLANTS EASILY BECAUSE THE HEAD JUST FELL INTO VARIOUS COLLAPSE AND TAKE THE DEAD BONY FRAGMENTS. INITIAL SURGERY WAS ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.

  Patient problems: Necrosis; No Code Available; Pain

  MAUDE report 8621210 ↗

Recalls under the same FDA submission

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

• 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
• 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