MULTILOC 04.018.225SRecalls & reported problems
Synthes GmbH · 8.5MM 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 10886982089458), received between Jun 23, 2020 and Oct 21, 2022 — classified as 2 injuries.
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 Problem2
Patient problems
- Failure of Implant1
- No Code Available1
- Wound Dehiscence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS FRACTURE FIXATION OF THE LONG BONES OCCURRED. THERE WAS WOUND DEHISCENCE WITH SURGICAL INTERVENTION. THIS REPORT INVOLVES ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 15651678 ↗InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF ONE (1) MULTILOC HUMERAL NAIL, THREE (3) UNKNOWN 4.5MM MULTILOC SCREWS, ONE (1) UNKNOWN 3.5MM LOCKING SCREW AND TWO (2) UNKNOWN 4.0MM LOCKING SCREWS. IT IS UNKNOWN WHAT WAS THE REASON FOR THE REMOVAL OF THE DEVICES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: SCREWS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 3), SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS REPORT INVOLVES ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL RIGHT/ CANN/ 225MM-STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 10183646 ↗
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
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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