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Arthrex® AR-7000-07Recalls & reported problems

Arthrex, Inc. · CORACOID DRILL GUIDE · Class 1

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867040854), received between Oct 31, 2022 and Feb 3, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 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: 1 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

  • Break3
  • Manufacturing, Packaging or Shipping Problem1
  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Insufficient Information2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 3, 2026Break

    ON 13-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7000-07 CORACOID DRILL GUIDE BROKE. THIS WAS DISCOVERED DURING A LATARJET CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24248247 ↗
  • MalfunctionNov 7, 2024Material Fragmentation; Material Fragmentation

    ON 10/23/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06693147 THAT AN AR-7000-07 CORACOID DRILL GUIDE PRODUCED METAL DEBRIS. THIS OCCURRED DURING WHEN THEY TRIED TO DRILL HOLES IN THE CORACOID THERE WAS A LOT OF METAL DEBRIS FROM THE REAMER.

    Patient problems: Insufficient Information

    MAUDE report 20632034 ↗
  • MalfunctionMay 26, 2024Break; Break

    IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE BROKE AT THE WELD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19398959 ↗
  • MalfunctionOct 31, 2022Break; Manufacturing, Packaging or Shipping Problem; Break

    ON 17-OCT-2022, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT A AR-7000-07, CORACOID DRILL GUIDE HANDLE CLASP WAS BROKEN. THIS WAS DISCOVERED DURING USE AND A CASE WAS INVOLVED. TO COMPLETE THE PROCEDURE, THE INSTRUMENT WAS USED MANUALLY BY HOLDING ONTO HANDLES TO SUPPORT GUIDE WHILST DRILLING. DRILL WAS BROKEN WHEN SENT INTO HOSPITAL.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 15698553 ↗

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Sources and updates

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