NA 03.008.005Recalls & reported problems
Synthes GmbH · DRIVING CAP F/HINDFOOT ARTHRODESIS NAIL-EX · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982066848), received between Feb 7, 2020 and Feb 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Device-Device Incompatibility
IT WAS REPORTED THAT CONNEC F/EXPERT HAN F/03.008.007, TNA CONNECTING TUBE TNA ARM, AND AIMING ARM ASSEMBLY TNA ARM WERE INVOLVED IN AN EVENT WHERE THE STRIKE CAP AND TNA CONNECTING TUBE BECAME WEDGED TOGETHER, MAKING IT IMPOSSIBLE FOR STAFF TO DISASSEMBLE THE DEVICES. ATTEMPTS TO REMOVE THE COMPONENTS PLACED SIGNIFICANT STRESS ON THE PATIENT, LEADING TO A CHANGE IN THE REMOVAL APPROACH. ALL THREE PIECES REMAINED STUCK TOGETHER AFTER THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR CLINICAL SYMPTOMS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24365536 ↗MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHRODESIS PROCEDURE, THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490590 ↗MalfunctionFeb 7, 2020Break; Break
IT WAS REPORTED ON (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) NOTICED THAT THE TWO (2) DRIVE SHAFTS, A UNIVERSAL CHUCK AND A DRIVING CAP WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRIVING CAP F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9684695 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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