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Arthrex® AR-13200ST-17.5Recalls & reported problems

Arthrex, Inc. · PLT,TIB A/P SLPD OSTEO · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867009684), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 3, 2023Break; Break

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-13280-35 AND AR-13280-50 CANCELLOUS SCREW BROKE POST-OPERATIVE. THIS WAS DISCOVERED DURING A POST-OPERATION FOLLOW-UP X-RAY ON (B)(6) 2023. THE PATIENT HAS COMPLAINED OF A SENSATION OF INSTABILITY BUT DOES NOT REPORT A SPECIFIC EVENT OR TIME FRAME IN WHICH THE INSTABILITY STARTED. THE IMPLANTS ARE STILL IN THE PATIENT, AND REVISION SURGERY HAS NOT OCCURRED YET. ADDITIONAL INFORMATION RECEIVED ON 6/8/2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2022, AND REVISION SURGERY OCCURRED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/16/2023: DURING THE REVISION SURGERY, AN ABS-3016 SYNTHETIC BONE FILLER, AN AR-13200ST-17.5 TIBIAL A/P SLOPED OSTEOTOMY PLATE, THREE AR-13370-4 OSFERION OSTEOTOMY WEDGE, AN AR-13380-40 CORTICAL SCREW, AND AN AR-13380-46 CORTICAL SCREW WERE EXPLANTED ALONG WITH THE BROKEN AR-13280-35 AND AR-13280-50 CANCELLOUS SCREW. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

    Patient problems: Insufficient Information

    MAUDE report 17247906 ↗

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Sources and updates

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