MULTILOC 04.016.225SRecalls & reported problems
Synthes GmbH · 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE · Class 2 · Implant
All models of MULTILOC (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982089250), received between Sep 29, 2020 and Dec 16, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Expiration Date Error” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Expiration Date Error1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2020Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN INTERMEDULLARY NAIL OF THE HUMERUS USING THE MULTILOC HUMERAL NAILING SYSTEM, THE NAIL THAT THE SURGEON WANTED WAS EXPIRED. THE SURGEON WANTED THE L 7MMX225MM HUMERAL NAIL AND ENDED UP USING AN UNKNOWN L 7MMX195MM HUMERAL NAIL. THE SURGEON WAS NOTIFIED OF OTHER DIAMETER OPTIONS OF THE SAME LENGTH AND THE SAME DIAMETER OPTIONS WITH DIFFERENT LENGTHS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11018874 ↗InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY OCCURRED DUE TO FRACTURE DISPLACEMENT AND IMPAIRED HEALING. NO IMPLANT MALFUNCTIONS OCCURRED. ALL HARDWARE WAS REMOVED. IT IS UNKNOWN WHAT IMPLANTS THE PATIENT WAS REVISED TO. THE ORIGINAL SURGERY AND IMPLANTATION WITH THE MULTILOC HUMERAL NAILING SYSTEM OCCURRED ON (B)(6) 2020. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 7 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 10599999 ↗
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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