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
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 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
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- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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