GUIDE WIRE GRIPPER 0481-100Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 2
Data updated Oct 13, 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 00848665010596), received between Jan 28, 2025 and Aug 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Difficult to Open or Close1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Difficult to Open or Close; Difficult to Open or Close
ON 08/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 0481-100 GUIDE WIRE GRIPPER HANDLE WOULD NOT STAY CLOSED OR CLAMPED WHILE THE SURGEON WAS MALLETING WIRE DOWN THE TIBIA CANAL. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921259 ↗MalfunctionJan 28, 2025Break; Break
ON 12/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE, VIA (B)(4), THAT AN 0481-100 GUIDE WIRE GRIPPER BROKE. THIS OCCURRED DURING AN ORIF HIP PROCEDURE ON (B)(6) 2024 THAT WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21254382 ↗
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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 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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