Arthrex® AR-1678-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867020863), received between Feb 1, 2021 and Dec 31, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionDec 31, 2025Break; Break

  ON 11TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1678-05, DRILL BIT FOR SWIVELOCK®, 3.5 MM, THE DRILL PIECE SNAPPED AND BROKE OFF DURING DRILLING. THIS WAS DETECTED DURING USE IN A BROSTRUM + INTERNAL BRACE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY USED A NEEDLE HOLDER TO REMOVE THE DRILL PIECE.

  Patient problems: Insufficient Information

  MAUDE report 23934191 ↗
• InjuryAug 25, 2025Break; Break

  ON 08/07/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1678-05 DRILL BIT FOR SWIVELOCK® BROKE. THIS OCCURRED DURING USE WHEN THE TIP BROKE OFF WHILE DRILLING THE BONE TO PLACE THE SWIVELOCK ANCHOR. A LARGER INCISION WAS MADE TO REMOVE THE DRILL BIT, BUT THIS DID NOT HAVE A NEGATIVE IMPACT. THE TECHNIQUE USED WAS ADJUSTED BECAUSE THE PATIENT WAS DIABETIC AND THE BONE WAS VERY DRY, WITH LITTLE IRRIGATION. THE PROCEDURE WAS COMPLETED NORMALLY, AND WHEN THE DRILL BROKE, IT HAD ALREADY PERFORMED THE INTENDED FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883132 ↗
• MalfunctionAug 20, 2025Break; Break

  ON 08/05/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1678-05 DRILL BIT FOR SWIVELOCK BROKE. THIS OCCURRED DURING A KNEE ARTHROSES PLUS ACL WHERE THE FRAGMENT WAS RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 22853153 ↗
• MalfunctionMay 24, 2024Break; Break

  A DRILL BIT WAS DAMAGED IN THEATRE. THE NATURE OF THE DAMAGE: BENT AT THE TIP, STILL INTACT, NO LOOSE FRAGMENTS. IT WAS SAFELY REMOVED FROM THE PATIENT WITHOUT CAUSING HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391151 ↗
• MalfunctionFeb 1, 2021Break

  IT WAS REPORTED THAT DURING A SWIVELOCK ELBOW SURGERY WHILE DRILLING THE ELBOW THE DEVICE BROKE OFF. IT WAS FURTHER REPORTED THAT A DRILL GUIDE WAS USED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 11258799 ↗