AOS THREADED HALF PIN (AO STYLE) 2.0mm x 55mm x 15mm 1411-055Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 2
- 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 00848665022308), received between Jun 4, 2024 and Jun 4, 2024 — classified as 1 malfunction.
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
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2024Break; Break
ON 7/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) 1411-055 THREADED HALF PIN BROKE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 7/14/2022: PATIENT UNDERWENT A WRIST EX-FIX FOR A BADLY COMMINUTED DISTAL RADIUS PROCEDURE ON (B)(6) 2022. WHILE THE PATIENT WAS TYPING, THE IMPLANTS BROKE AND THE SURGEON WAS ALERTED IMMEDIATELY. PER SALES REPRESENTATIVE, REVISION SURGERY HAS NOT TAKEN PLACE TO REMOVE THE IMPLANTS, HOWEVER, IT IS BELIEVED THAT ON OF THE PINS WILL REMAIN IN THE PATIENT BECAUSE IT'S FLUSHED WITHIN CORTICES AND RETRIEVING IT WOULD CAUSE MORE HARM THAN GOOD. THE OTHER IS TO BE REMOVED AT THE TIME OF DEFINITIVE FIXATION - AS THAT BROKEN FRAGMENT IS PROTRUDING FROM BONE AND WILL CAUSE SOFT TISSUE IRRITATION. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Failure of Implant
MAUDE report 19461931 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.