NA 03.010.202Recalls & reported problems
Synthes GmbH · SURELOCK CONNECTOR-RIGHT ANTEGRADE FEMORAL NAILS · Class 1
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 10886982068057), received between Feb 28, 2018 and Feb 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, SURGERY FOR FEMORAL DIAPHYSEAL FRACTURE WAS PERFORMED USING THE SURELOCK DISTAL TARGETING DEVICE. INTRAOPERATIVELY, TWO EVENTS WERE CONFIRMED BY THE SURGEON. THE DRILL BIT HIT THE NAIL. THE INSERTION OF LOCKING SCREW 5.0 MM/34MM WAS SUCCESSFUL AT THE SECOND HOLE FROM THE DISTAL END. HOWEVER, THE DRILL BIT HIT THE NAIL WHEN DRILLING AT THE MOST DISTAL OVAL HOLE. A LOCKING SCREW 5.0MM/36MM WAS INSERTED AT THE OVAL HOLE. SECONDARILY, THE SURGEON CONFIRMED UNDER THE IMAGE THAT THIS LOCKING SCREW 5.0MM/36MM, WHICH WAS INSERTED AT THE OVAL HOLE, WAS BEING OUT OF BOUNDS (NOT INSERTED TO THE SCREW HOLE). HE COULD NOT REMOVE THIS SCREW, SO HE LEFT THE SCREW IN THE BONE. THEN, BY USING RADIOLUCENT DRIVE, HE DRILLED AT THE OVAL HOLE AND INSERTED A LOCKING SCREW AT THE DISTAL FAR END. THE SURGERY WAS COMPLETED WITH A 20-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES: DRILL BIT (PART# 03.010.061, LOT# UNKNOWN, QTY 1); SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN) ; LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN) ; FEMORAL NAIL (PART#
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7302904 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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