INTRAFIX 254653Recalls & reported problems
Depuy Mitek, LLC · INTRAFIX PEEK Tapered Screw 7-9mm x 30mm · Class 2 · Implant
All models of INTRAFIX (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705022397), received between Jul 12, 2022 and Jul 23, 2025 — classified as 3 injuries.
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
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Unspecified Tissue Injury3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS REPORT 7 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER DUA-SPORTS-2024-017 CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX PEEK TPR SCR, 7-9MMX30MM DEVICE FAILED AND THE PATIENT REQUIRED A RE-OPERATION OR REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22579229 ↗InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS REPORT 6 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX ® PEEK TAPERED SCREW 7-9MM X 30MM DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 17309058 ↗InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS ((B)(4)) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX ® PEEK TAPERED SCREW 7-9MM X 30MM DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 14991143 ↗
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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