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Arthrex® AR-8979P-1Recalls & reported problems

Arthrex, Inc. · DX Swivelock, 3.5 x 13.5 mm · Class 2 · Implant

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

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867287709), received between Dec 13, 2021 and Feb 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break1
  • Device Dislodged or Dislocated1
  • Material Twisted/Bent1
  • Positioning Failure1
  • Therapeutic or Diagnostic Output Failure1
  • Unstable1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Foreign Body In Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 23, 2026Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE ANCHOR WAS PULLED OUT OF THE BONE. 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 24416253 ↗
  • MalfunctionNov 14, 2025Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE DID NOT GRIP. 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 23556617 ↗
  • MalfunctionMay 24, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING AN INTERNAL BRACE ANKLE JOINT SURGERY THE ANCHOR BECAME BENT. IT WAS FURTHER REPORTED THAT THE CUSTOMER HAS DRILLED, CUT THE THREAD AND USED THE CORRECT INSERTION DIRECTION. 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 19394250 ↗
  • MalfunctionJan 30, 2023Break

    IT WAS REPORTED THAT DURING A FOOT ARTHROSCOPY THE IMPLANT BROKE. THE DEVICE BROKE BEFORE THE INSERTION IN THE PATIENT. 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. UPDATE (B)(6) 2023: FURTHER INFORMATION REVEALED THAT THE DEVICE BROKE INSIDE THE PATIENT. THE DEVICE WAS NOT REMOVED BUT DID NOT OBSTRUCT FURTHER STEPS IN THE OPERATION.

    Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

    MAUDE report 16263502 ↗
  • MalfunctionDec 13, 2021Unstable; Therapeutic or Diagnostic Output Failure

    IT WAS REPORTED THAT DURING A SURGERY IMPLANT FAILED TO ANCHORAGE AND REMAINED UNSTABLE. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY . NO FURTHER INFORMATION RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12983508 ↗

Other Fastener, fixation, nondegradable, soft tissue devices

All Fastener, fixation, nondegradable, soft tissue devices →

Sources and updates

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