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Arthrex® AR-5875GRecalls & reported problems

Arthrex, Inc. · GAP Drill Guide · Class 1

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867307506), received between Sep 7, 2021 and Apr 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break3
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 21, 2025Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY A PART OF THE DEVICE BROKE OFF AND DAMAGED TWO ANCHORS. 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 21876517 ↗
  • MalfunctionFeb 24, 2025Break; Break

    IT WAS REPORTED THAT DURING A KNEE CAPSULE REPAIR SURGERY THE TIP OF THE DEVICE BROKE OFF. 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 21445693 ↗
  • MalfunctionJan 16, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT DURING A MENISCUS EXTRUSION SURGERY THE SETTING TOOL DETACHED FROM THE TARGET GUIDANCE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 14-JAN-2025: RECEIVED FURTHER INFORMATION THAT DURING A MEDIAL MENISCOTIBIAL LIGAMENT REPAIR SURGERY THE TIP BROKE OFF WHILE PLACING THE SETTING TOOL OVER THE DRILL WIRES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21170331 ↗
  • MalfunctionSep 7, 2021Break

    IT WAS REPORTED THAT DURING A MENISCOTIBIAL CAPSULE RE-FIXATION SURGERY THE DEVICE BROKE OFF WHILE ALIGNING THE DEVICE DURING THE PLACEMENT OF THE THIRD ANCHOR. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. THE DEVICE WORKED AS INTENDED FOR THE FIRST TWO ANCHORS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. THE THIRD ANCHOR WAS PLACED SUCCESSFULLY BY ALIGNING THE DEVICE IN A FREEHAND WAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12434078 ↗

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Sources and updates

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