Click'X 388.354Recalls & reported problems
Synthes GmbH · SCREWDRIVER FOR TI CLICK'X® LOCKING CAP · Class 1
All models of Click'X (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034772523), received between Aug 21, 2018 and Nov 19, 2021 — classified as 2 malfunctions.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2021Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PART OF THE SCREWDRIVER WAS BENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SCREWDRIVER FOR TI CLICK'X® LOCKING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12845135 ↗MalfunctionAug 21, 2018Break; Break
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT REMOVAL SURGERY TO REMOVE LOCKING NUTS AND RODS. DURING THE SURGERY, THE SURGEON NOTED THAT THE END OF ONE LOCKING CAP SCREWDRIVER WAS BENT AND DID NOT ENGAGE WELL. ADDITIONALLY, A PIECE OF THE SECOND SCREWDRIVER WAS SNAPPED OFF. IT IS UNKNOWN WHEN THIS OCCURRED. PATIENT WAS EXAMINED FOR METAL AND X-RAYS WERE DONE. NO TRACE OF METAL FOUND. THE PROCEDURE WAS PROLONGED FOR UNKNOWN LENGTH OF TIME WHILE ATTEMPTING TO UNLOCK THE LOCKING CAP. PROCEDURE WAS COMPLETED. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) SCREWDRIVER FOR TI CLICK'X® LOCKING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7801015 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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