NA 388.079Recalls & reported problems
Synthes GmbH · 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC · Class 1
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 10705034771809), received between Jul 12, 2018 and Oct 15, 2019 — 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 Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2019Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON A UNKNOWN DATE DURING A LUMBAR ARTHRODESIS PROCEDURE THE SURGEON WAS UNABLE TO ADJUST THE TWO (2) LOCKING CAPS AND COULD NOT INSERT THE TWO (2) CROSS-LINK CLAMPS. DURING SURGERY THE TWO SCREWDRIVERS FAILED. THE PATIENT STATUS IS STABLE. CONCOMITANT MEDICAL PRODUCTS: CLICKX LOCKCAP (PART# 498.570, LOT# UNKNOWN, QUANTITY UNKNOWN). CROSS-LINK-CLAMP FOR ROD (PART# 498.813, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT 3.5 W/HEXQUICK-COUPL 6 F/. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9193501 ↗MalfunctionJul 12, 2018Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, TWO (2) HEXAGONAL SCREWDRIVER SHAFTS WERE DEFECTIVE. THE TWO SCREWDRIVERS DUSTED ONE OF THE LAST SCREWS THAT THE SURGEON WAS IMPLANTING. THERE WAS A SURGICAL DELAY FOR ABOUT TWO (2) HOURS. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7683574 ↗
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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