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Arthrex® AR-1670PSRecalls & reported problems

Arthrex, Inc. · TENO SCRW,PEEK,VENT · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00888867020757), received between Sep 12, 2024 and Sep 12, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Deformation1

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.

  • MalfunctionSep 12, 2024Material Deformation; Material Deformation

    ADDITIONAL INFORMATION RECEIVED ON 9/9/2024: THE SUTURES OF A KNOTLESS BICEP BUTTON FROM AN AR-2280 RIPPED, AND THE BICEP WAS UNABLE TO BE TIGHTENED. EVERYTHING WAS SUCCESSFULLY REMOVED FROM INSIDE THE PATIENT. AR-1670PS PEEK TENODESIS SCREW DID NOT BREAK, ONLY STRIPPED DURING INSERTION. THE CASE WAS COMPLETED USING A NEW AR-1670PS PEEK TENODESIS SCREW AND AR-2280 KNOTLESS DISTAL BICEPS. ADDITIONALLY, DURING THE PROCEDURE, WHEN AN AR-1255-18 SUTURE PASSING WIRE WAS OPENED, IT WAS MISSING THE EYELET LOOP AT THE END. A SECOND AR-1255-18 SUTURE PASSING WIRE WAS USED INSTEAD.

    Patient problems: Insufficient Information

    MAUDE report 20200613 ↗

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Sources and updates

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