MULTILOC 04.019.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982089847), received between Sep 5, 2018 and Oct 5, 2020 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionOct 5, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4.5 MM MULTILOC SCREW WAS MISSING IN THE SCREW PACKET THAT WAS RECEIVED. IT WAS OBSERVED THAT THE PACKET HAD NOT BEEN TAMPERED WITH OR OPENED SINCE IT STILL HAD THE PERFORATED LINE. THE ISSUE WAS DISCOVERED UPON RECEIVING SHIPMENT RESTOCK. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.5 MM TI MULTILOC SCREW LENGTH 42 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10631486 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD HARDWARE REMOVAL OF 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 REMOVED ALL THE IMPLANTS BECAUSE THE HEAD JUST FELL INTO VARIOUS COLLAPSE AND TAKE THE DEAD BONY FRAGMENTS. INITIAL SURGERY WAS DONE ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM TI MULTILOC SCREW 42MM. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis; No Code Available; Pain

  MAUDE report 8621240 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF THREE (3) TITANIUM (TI) MULTILOC SCREWS DUE TO LEFT SHOULDER PAIN. ALL OF THE SCREWS WERE REMOVED INTACT WITHOUT ANY PROBLEM. THE MULTILOC HUMERAL NAIL WAS LEFT IN THE PATIENT. THE SURGEON DECIDED TO LEAVE THE NAIL IN PLACE AS IT WAS NOT STICKING OUT NOR WAS THERE A MALFUNCTION WITH AND HE FELT THE SCREWS WERE THE CAUSE OF THE PAIN. IT WAS NOT PROVIDED IF THERE WAS ANY OTHER MEDICAL INTERVENTION DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS NOT PROVIDED. CONCOMITANT DEVICE: MULTILOC HUMERAL NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A 4.5MM TI MULTILOC SCREW LENGTH 42MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7847308 ↗

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