Arthrex® AR-8935-34Recalls & reported problems
Arthrex, Inc. · LO-PRO SCRW,TI,3.5MMX 34MM · 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 00888867050600), received between Apr 18, 2019 and Apr 18, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
- Patient-Device Incompatibility1
Patient problems
- Itching Sensation1
- Sleep Dysfunction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem
IT WAS REPORTED BY A PATIENT, THROUGH THE ARTHREX WEBSITE, THAT SHE HAD UNDERGONE A CALCANEUS REPAIR PROCEDURE (B)(6) 2017. LESS THAN TWO WEEKS POST SURGERY PATIENT'S BACK STARTED ITCHING AND THIS HAS SINCE SPREAD ALL OVER HER BODY AND PATIENT REPORTS THIS IS CAUSING HER GREAT STRESS AND LACK OF SLEEP. AT THE TIME OF INITIAL REPORT THE PATIENT DID NOT HAVE THE ARTHREX PRODUCT NUMBERS FOR HER IMPLANTS. PATIENT HAS REQUESTED AND WILL BE PROVIDED WITH THE MATERIAL COMPOSITION OF HER IMPLANTS ONCE THE PART NUMBERS ARE PROVIDED TO ARTHREX. ADDITIONAL INFORMATION OBTAINED 4/3/2019: PATIENT HAS PROVIDED THE IMPLANT LOG FROM HER SURGERY. THE FOLLOWING ARE THE PATIENT'S ARTHREX IMPLANT PART NUMBERS. LOT NUMBERS WERE NOT PROVIDED ON THE IMPLANT LOG AND ARE NOT AVAILABLE: CALCANEUS PLATE: AR-8954PR-XS (QTY 1), 3.5MM LOCKING SCREWS: AR-8935L-28 (QTY2), AR-8935L-22 (QTY 1), 3.5MM NON-LOCKING SCREWS:(QTY 1 EACH) AR-8935-38, AR-8935-36, AR-8935-34, AR-8935-30, AR-8935-26, AR-8935-24. MATERIAL COMPOSITION OF THE IMPLANTED DEVICES IS BEING PROVIDED TO THE PATIENT.
Patient problems: Itching Sensation; Sleep Dysfunction
MAUDE report 8526645 ↗
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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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