Arthrex® AR-3657Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867225428), received between May 22, 2025 and Jul 15, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829963 ↗
• MalfunctionJul 13, 2026Break

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF SPEEDFIX SURGERY, THE TIP OF THE DRILL BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. 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 25798627 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE GOT BENT DUE TO THE CONTINUED USE. THIS WAS NOTICED BEFORE SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 03-MAR-2026: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED ISSUE WAS NOTICED AFTER THE LAST USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638726 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE COLLAR OF THE WICK HAS COME OFF DURING MECHING. 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. UPDATE 19-MAY-2025 -SAC: RECEIVED FURTHER INFORMATION THAT THE CORRECT FAILURE DESCRIPTION IS THAT THE ROUND METALIC PART DISCONNECTED FROM THE DRILL DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072470 ↗