NA 03.010.481Recalls & reported problems
Synthes GmbH · RADIOLUCENT AIMING ARM FOR RETROGRADE STANDARD LOCKING · Class 2
Data updated Oct 18, 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 10886982068996), received between Jun 23, 2020 and Feb 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K033618); they may or may not involve this specific model.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, PRIOR TO THE PROCEDURE, THE TECHNICIAN WAS UNABLE TO FULLY THREAD THE AIMING ARM INTO THE INSERTION HANDLE DESPITE IT THREADING 80 PERCENT OF THE WAY WITHOUT RESISTANCE. ANOTHER SET (TIBIAL NAIL SET) WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY OR COMPLICATIONS. CONCOMITANT DEVICE REPORTED: RETROGRADE AIMING ARM (PART: 03.010.481 ;LOT# UNKNOWN; QUANTITY:1). THIS REPORT IS FOR 1 RADIOLUCENT AIMING ARM FOR RETROGRADE STANDARD LOCKING THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11357817 ↗MalfunctionJun 23, 2020Break; Break
Recalls under the same FDA submission
These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.
- Z-2058-2013 · Nov 2, 2012 · TerminatedSynthes Trauma Nail System. The devices are indication for bone fixation.
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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