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Arthrex® AR-8750-01Recalls & reported problems

Arthrex, Inc. · DPTH DEV, CANN SCRWS · Class 1

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 00888867263604), received between Dec 11, 2025 and Dec 11, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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. How this data works · Data updated Oct 13, 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: 0 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: 1 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

  • Failure to Clean Adequately1

Patient problems

  • Bacterial Infection1
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryDec 11, 2025Failure to Clean Adequately; Failure to Clean Adequately

    ON 5TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8750-01, DEPTH DEVICE FOR CANNULATED SCREWS, BLOOD CLOT WAS FOUND IN THE INSTRUMENT DEPTH GAUGE. THIS WAS DETECTED DURING A SPRING LIGAMENT RECON PROCEDURE ON (B)(6) 2025. THE SURGEON CONTINUED USING THE AR-8750-01 AFTER SOAKING IT IN CHLORHEX. ADDITIONAL INFORMATION: THE HOSPITAL INFORMED ARTHREX SINGAPORE ON (B)(6) 2025 THAT THE PATIENT SUFFERED FROM SIDE EFFECT AFTER THE SURGERY. ADDITIONAL INFORMATION RECEIVED ON 10TH DEC 2025: THE PATIENT WENT BACK TO THE HOSPITAL FOR WOUND WASHOUT 3 TIMES DUE TO INFECTION.

    Patient problems: Bacterial Infection; Insufficient Information

    MAUDE report 23779822 ↗

Other GAUGE, DEPTH devices

All GAUGE, DEPTH devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.