Arthrex® AR-5875-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867307513), received between Feb 1, 2021 and Oct 17, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 17, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-5875-2 KNEE CAPSULE REPAIR IMPLANT SYSTEM WITH GAP DRILL GUIDE FAILED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17951507 ↗
• MalfunctionAug 11, 2023Break; Break

  ON 07/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-5875-2 KNEE CAPSULE REPAIR IMPLANT SYSTEM, PIECE OF GUIDE BROKE OFF DURING INSERTION OF THE IMPLANT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17513010 ↗
• MalfunctionNov 11, 2021Break; Entrapment of Device

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-5875-2 DRILL GUIDES SNAPPED. THIS OCCURRED ON (B)(6) 2021 DURING A MENSICO-CAPSULAR REPAIR IN CONJUNCTION WITH A MENISCAL ROOT REPAIR. AFTER THE SURGEON PERFORMED THE ROOT PORTION OF THE PROCEDURE, HE HAD PLACED THE GUIDEWIRES AND BEGAN DRILLING FOR HIS SUTURE TAKS. UPON INSERTION OF THE SECOND ANCHOR THE GAP GUIDE SNAPPED, CAUSING THE TEAM TO SKIVE WITH THE ANCHOR. A SECOND KIT WAS OPENED UP FOR THE GUIDE, BUT UPON INSERTING THE ANCHOR, THE GAP GUIDE BROKE WITH THE ANCHOR STAYING IN THE BONE. FOR THE THIRD ANCHOR THE SURGEON CHOSE TO FREEHAND THE DRILL INSTEAD OF OPENING ANOTHER KIT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12793537 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED DURING A CAPSULAR REPAIR OF THE KNEE, THE PURPLE HANDLED GAP GUIDE BROKE UNDER A SMALL AMOUNT OF TENSIONING/LEVERING. THE SHORTER GUIDE COMPONENT FOR THE WIRES SNAPPED OFF THE LARGER DRILL GUIDE. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 11871696 ↗
• MalfunctionFeb 1, 2021Break

  IT WAS REPORTED THAT DURING A KNEE CAPSULE REPAIR PROCEDURE THE SURGEON WAS USING AR-5875-2, ARTHREX KNEE CAPSULE REPAIR SYSTEM (LOT 12170195). DURING USE THE GUIDE FROM THE KIT BROKE. SURGEON THEN TRIED FREE-HANDING THE GUIDE'S POSITION AND BOTH ANCHORS PULLED OUT. ADDITIONAL INFORMATION OBTAINED 01/20/2021: DATE OF PROCEDURE WAS (B)(6) 2021. ALL COMPONENTS/PIECES OF THE AR-5875-2 WERE FULLY RETRIEVED AND NOTHING WAS LEFT IN THE PATIENT. THE SURGEON THEN USED SUTURE TO COMPLETE HIS REPAIR. ALL COMPONENTS OF THE COMPLAINT DEVICE WERE DISCARDED AT THE TIME OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258741 ↗