Arthrex® AR-1320DSCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867009851), received between Aug 31, 2016 and Mar 2, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2017Break; Detachment Of Device Component; Entrapment of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY CASE, THE TIP OF THE DRILL BIT THAT'S INCLUDED WITH THE DISPOSABLE INSTRUMENT KIT FOR MICRO SUTURE-TAK, BROKE OFF INTO THE PATIENT'S BONE. THE SURGEON PERFORMED AN X-RAY TO CONFIRM IF THE PIECE WAS STILL IN THE PATIENT AND IT WAS. NO ATTEMPTS WERE MADE TO RETRIEVE THE PIECE AS IT WAS TOO FAR LODGED INTO THE PATIENT'S BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6371759 ↗
• InjuryAug 31, 2016Failure To Adhere Or Bond; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A HAND TFCC RECONSTRUCTION PROCEDURE THE DISPOSABLE KIT AR-1320DSC LOT 1188386 ((B)(4)) DID NOT HAVE THE NECESSARY DRILL SLEEVE. THE SURGEON DRILLED FOR THE ANCHORS WITHOUT USING A DRILL SLEEVE. AS A RESULT THE ANCHORS AR-1320BCNF, LOT 1304766 (QTY 2) ((B)(4)) WERE NOT SECURE AND PULLED OUT. THE PROCEDURE WAS NOT COMPLETED AS PLANNED. INSTEAD THE PROCEDURE WAS COMPLETED BY CHANGING THE TECHNIQUE AND USING BONE TUNNELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5918035 ↗