NA 04.033.140SRecalls & reported problems
Synthes GmbH · 11MM / TI CANN FRN / PF 400MM / RIGHT - STERILE · Class 2 · Implant
Data updated Oct 18, 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 10886982272454), received between May 16, 2019 and Jul 1, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Failure of Implant1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 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 A HARDWARE REMOVAL OF INFECTED FEMORAL RECON NAIL (FRN) AND INSERTION ON AN ANTIBIOTIC NAIL. THE FRACTURE WAS HEALED, AND HARDWARE WAS INTACT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE INFECTION. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 11MM / TI CANN FRN / PF 400MM / RIGHT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10218834 ↗InjuryMay 16, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION NAILING PROCEDURE TO REMOVE THE BROKEN NAIL WITH A NEW NAIL IMPLANTED. THE PATIENT WAS FIRST TREATED ON (B)(6) 2018, THE PATIENT FOLLOWED UP WITH A BROKEN NAIL. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY 1), RECON SCREW (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 8617126 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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