Arthrex® AR-8943-15-1Recalls & reported problems
Arthrex, Inc. · Depth Device, 2.7/3.5/4.0mm, Slider Asm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867132290), received between Mar 18, 2024 and Jan 12, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
- Foreign Body In Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Break
ON 29-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15-1 DEPTH DEVICE IS BROKEN AT THE WELDED JOINT. NOTICED DURING A CASE BUT WAS NOT BROKEN WITHIN PATIENT.
Patient problems: Insufficient Information
MAUDE report 24044174 ↗MalfunctionMay 12, 2025Break; Break
ON 04/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT 2 AR-8943-15-1 DEPTH DEVICES MEASURING PROBE BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003722 ↗MalfunctionMay 12, 2025Break; Break
ON 04/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT 2 AR-8943-15-1 DEPTH DEVICES MEASURING PROBE BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003635 ↗MalfunctionApr 18, 2025Break; Break
ON 03/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-8943-15 DEPTH DEVICE WAS INSERTED INTO AN AR-8943-15-1 SLIDER AND WHEN THE DEPTH DEVICE ENTERED THE BONE, IT BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ANOTHER DEVICE WAS SWAPPED, AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21866879 ↗MalfunctionFeb 13, 2025Break; Break
ON 01/24/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8943-15-1 DEPTH DEVICE BROKE. THIS OCCURRED DURING A CLAVICLE FRACTURE WHEN THE DEVICE BROKE INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 21374545 ↗MalfunctionJun 6, 2024Break; Break
ON 05/09/2024 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15-1 DEPTH DEVICE SLIDER TIP IS BROKEN. CASE/PATIENT INVOLVEMENT NOT INDICATED.
Patient problems: Insufficient Information
MAUDE report 19475283 ↗MalfunctionMar 18, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06502765 THAT AN AR-8943-15-1 SLIDER MEASURING NEEDLE BROKE. SWAPPED DEVICE TO COMPLETE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923771 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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