NA 03.233.009Recalls & reported problems
Synthes GmbH · HOLDING DEVICE HANDLE F/ LOCKING ATTACHMENT WASHER · Class 1
Data updated Oct 16, 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 10886982288370), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON WAS INSERTING A RETROGRADE FEMORAL NAIL ADVANCED (RFNA) WITH THE LOCKING ATTACHMENT WASHER (LAW) ADJUNCT. WHEN ATTEMPTING TO PLACE THE LAW PLATE USING THE HOLDING DEVICE HANDLE, DESPITE FULLY THREADING THE HOLDING DEVICE LOCKING PIN, ALL THE WAY INTO THE LAW PLATE, THE LAW PLATE KEPT FALLING OFF/BECOMING LOOSE FROM THE LOCKING PIN. THE PROCEDURE PROCEEDED WITHOUT THE HOLDING DEVICE HANDLE/LOCKING PIN. ON SURGICAL BACK TABLE, THE INSTRUMENTS WERE INSPECTED AND IT APPEARED THE THREADS ON THE FAR END OF LOCKING PIN LOOKED DAMAGED. THERE WAS NO SURGICAL DELAY DUE TO REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE NOT GENERATED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20534455 ↗
Other Guide, surgical, instrument devices
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- 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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