Arthrex® AR-8835-30Recalls & reported problems
Arthrex, Inc. · LO-PRO SCRW TM,SS 3.5X 30MMCORT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00888867047365), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Anxiety1
- Bradycardia1
- Fatigue1
- Palpitations1
- Sleep Dysfunction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY A DERMATOLOGIST'S OFFICE THAT A PATIENT IS CONCERNED HE IS ALLERGIC TO A COMPONENT OF THE PLATE AND SCREWS USED TO FIX HIS ANKLE IN 2015 AFTER HE SUFFERED A BREAK. REPORTER HAS REQUESTED MATERIAL COMPOSITION OF THE DEVICES. THE FOLLOWING ARE THE IMPLANTED DEVICES: AR-8943TH-05, LOCKING LATERAL HOOK PLATE, STAINLESS STEEL ((B)(4)). AR-8835-30, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-18, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-14, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8840-14, LOW PROFILE CANCELLOUS SCREW, STAINLESS STEEL ((B)(4)). AR-8926SS, KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT. FOLLOW-UP INVESTIGATION: PATIENT'S ORIGINAL SURGERY WAS IN (B)(6) 2014 (NOT 2015 AS ORIGINALLY REPORTED). SPECIFIC DATE IS UNKNOWN. SURGERY WAS AN ORIF OF THE LEFT ANKLE. PATIENT IS A MALE WITH KNOWN ALLERGY TO AMOXICILLIN. PATIENT HAS BEEN EXPERIENCING CHRONIC FATIGUE AND SLEEPINESS, ANXIETY AND PALPITATIONS AND BRADYCARDIA. TREATMENTS TO DATE ARE UNKNOWN. MATERIAL COMPOSITION OF THE IMPLANTED DEVICES HAS BEEN PROVIDED THE REPORTER. DEVICES ARE STAINLESS STEEL. SINCE A SPECIFIC DAY FOR THE ORIGINAL (B)(6) 2014 SURGERY
Patient problems: Anxiety; Bradycardia; Fatigue; Palpitations; Sleep Dysfunction
MAUDE report 7285133 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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