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Arthrex® AR-8990-1Recalls & reported problems

Arthrex, Inc. · DX FiberTak Suture Anchor, #1 FW & NDLs · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867264991), received between Nov 9, 2022 and Jan 28, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated3
  • Break2
  • Positioning Failure2
  • Activation, Positioning or Separation Problem1
  • Defective Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 28, 2026Positioning Failure

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE IMPLANT DID NOT ANCHOR AFTER BEING INSERTED INTO THE CANAL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24198549 ↗
  • MalfunctionSep 12, 2025Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE IMPLANT DID NOT ANCHOR. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23038045 ↗
  • MalfunctionJun 20, 2025Break; Break

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE DEVICE BROKE DURING INSERTION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22298889 ↗
  • MalfunctionOct 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING AN ANKLE INSTABILITY SURGERY THE IMPLANT PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20521358 ↗
  • MalfunctionOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SUTURING OF THE MENISCUS THE ANCHOR SLIPPED OUT OF THE BONE AND THE SUTURE DID NOT STAY IN THE PLACE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20383490 ↗
  • MalfunctionJun 19, 2024Defective Device; Defective Device

    IT WAS REPORTED THAT DURING AN ELBOW SURGERY THE IMPLANT DID NOT GET BLOCKED DURING ANCHOR INSERTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19570780 ↗
  • MalfunctionFeb 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING A LUXATION REPAIR SURGERY THE IMPLANT SLIPPED OUT OF THE PREPARED CHANNEL IN THE BONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18693978 ↗
  • MalfunctionNov 9, 2022Break

    IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE ANCHOR OF THE DEVICE BROKE DURING INSERTION. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15758598 ↗

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Sources and updates

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