Arthrex® AR-4030P-07Recalls & reported problems
Arthrex, Inc. · Ø7X 30MM PEEK IF SCRW NON-VENTED · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867295049), received between Jul 24, 2023 and Sep 21, 2026 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
- Use of Device Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Use of Device Problem
It was reported that during a surgery that the screws are not providing sufficient fixation. As a result, instead of using two screws as initially planned, they are sometimes required to use additional screws or a larger size to finish the surgery successfully. Per complaint reporter there was no harm for patient, operator or third party. It was not necessary to switch the surgical technique or do a second surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838389 ↗InjuryJul 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
ON 06/27/2023, IT WAS REPORTED BY A RELATIVE OF A PATIENT, VIA PHONE, THAT THE PATIENT IS EXPERIENCING A REACTION 3 WEEKS AFTER UNDERGOING A RIGHT DE ROTATIONAL FEMORAL OSTEOTOMY WITH ALLOGRAFT AND MPSL RECONSTRUCTION WITH ALLOGRAFT ON (B)(6) 2023 IN WHICH (2) AR-8934BCST SUTURE TAPES, AN AR-8719MXDS-2015 DYNANITE STAPLE, AND AN AR-4030P-07 PEEK INTERFERENCE SCREW WERE IMPLANTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING A BREAKOUT OF HIVES. THE PATIENT IS BEING TREATED WITH STEROIDS AND OTHER ANTIHISTAMINES THAT ARE KEEPING HER STABLE. THE PATIENT IS AWAITING ALLERGY TESTING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17378459 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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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