MULTILOC 04.019.195SRecalls & reported problems
Synthes GmbH · 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/195MM-STERILE · Class 2 · Implant
All models of MULTILOC (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982090058), received between Jan 5, 2022 and Jan 5, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE MULTILOC HUMERAL NAIL WAS HITTING THE NAIL, THE CABLE LOCK FOR CABLE TENSIONER DID NOT LOCK WHILE PISTOL GRIPPING, AND THE PARALLEL WIRE GUIDE DIDN¿T NEED FEED WIRE THROUGH WAS BENT. THERE WERE FOUR MINUTES SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/195MM-STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13170796 ↗
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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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