Click'X 388.365Recalls & reported problems
Synthes GmbH · LONG SCREWDRIVER WITH T-HANDLE FOR CLICK'X® LOCKING CAP · Class 1
All models of Click'X (4)
Data updated Oct 18, 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 10705034772615), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (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
- Peeled/Delaminated1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2017Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INSTRUMENTS NEEDED TO BE REPAIRED, THE TIP OF THE FORK OF THE LONG SCREWDRIVER WITH T-HANDLER FOR CLICK X LOCKING CAP IS SLIGHTLY BENT AND WILL NOT ENABLE INTERFACING OR SELF-RETENTION OF A LOCKING SET SCREW/CAP FOR INSERTION; THE CONE TIP OF THE REMOBILIZER OF THE EXTRACTION PLIERS FOR CLICK X IS BROKEN FROM THE WELD AND NOT RELIABLE FOR SURGERY - IT STILL SLIDES ONTO THE 2-PIECE REMOBILIZER, BUT IS UNFIT FOR USE; THE TIPS OF THE DRIVER OF TWO SCREW INSERTERS T8 SELF-RETAINING/QC DO NOT SELF-RETAIN SCREWS. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. THERE IS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7032941 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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