NA SD03.010.129Recalls & reported problems
Synthes GmbH · AIMING SLEEVE W/ CROSS WIRES · 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 10886982306067), received between Feb 10, 2023 and Feb 10, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE, THE AIMING ARM AND GUIDE MISSED NAIL. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE STD LOCKING. THIS IS REPORT 4 OF 4 FOR COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16358412 ↗MalfunctionFeb 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE, THE AIMING ARM AND GUIDE MISSED NAIL. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE STD LOCKING. THIS IS REPORT 3 OF 4 FOR COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16358399 ↗
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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