NA 02.221.123Recalls & reported problems
Synthes GmbH · 3.5/4.5MM VA PPFX PROX FEMUR PLATE/10HOLES/LEFT · Class 2 · Implant
Data updated Oct 16, 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 10886982275745), received between Jun 7, 2022 and Apr 25, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent2
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2025Defective Device; Defective Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21913716 ↗MalfunctionNov 28, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE WARP INSERTION HANDLE, AIMING ARM, AND OUTER DRILL SLEEVE CROSS-THREADED ATTACHMENT PLATE TO PROX FEMUR PLATE. -RUSTED REMOVAL DEVICE. THE PRODUCT WAS SAID TO CONTAIN ¿RUST¿ FROM THE FACILITY. IT WAS DEEMED "UNUSABLE" AS A CONTAMINATION RISK. THERE WAS NO REVISION SURGERY OR HARDWARE REMOVAL. THE PATIENT WAS NOT AFFECTED, NOR WERE THEY CHARGED. THESE ARE NOT ITEMS OWNED BY THE HOSPITAL, NOR WERE THEY CHARGED. THIS REPORT IS FOR ONE (1) 3.5MM/4.5MM VA PROX FEMUR PL 322MM/LEFT THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18222221 ↗MalfunctionJun 7, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2022, 5.0 VA LOCKING SCREW WOULD NOT THREAD INTO THE PLATE IN TWO OF THE DISTAL INTERLOCKING HOLES. THE CORRECT DRILL GUIDE AND DRILL BIT WERE USED TO PREPARE FOR INSERTION BUT SCREWS STRIPPED OUT IN BOTH HOLES. ANOTHER PLATE WAS PLACED WITH SAME SCREWS WITH NO ISSUE. THERE WAS NO REPORTED SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES (1) 3.5/4.5MM VA PPFX PROX FEMUR PLATE/10HOLES/LEFT. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14622153 ↗
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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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