Arthrex® AR-7715-4.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867042087), received between Nov 11, 2021 and Nov 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021Device Markings/Labelling Problem

  ON 10/19/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-7715-4.5 UCL SUTURE PASSING DISPOSABLES KIT LABEL DESCRIBES TO HAVE A #2 FIBERLOOP WITH NEEDLE, #2 TIGERLOOP WITH NEEDLE, AND A CURVE NEEDLE WITH NITINOL LOOP AND RULER, WHICH WOULD MAKE A TOTAL OF 3 NEEDLES IN THE PACKAGE; HOWEVER, THE TOTAL NEEDLE COUNT IS LISTED ON LABEL AS 2. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME. ADDITIONAL INFORMATION: DURING THE SHOULDER PRODUCT QUALITY COMPLAINTS REVIEW MEETING ON 10/28/2021 THIS COMPLAINT WAS DISCUSSED AND IT WAS DETERMINED THAT A NEEDLE WAS LEFT IN A PATIENT, WHICH LED TO AN ADDITIONAL SURGERY TO REMOVE THE NEEDLE WHICH WAS LEFT BEHIND. THE LABEL DISCREPANCY WAS NOTICED AS A RESULT OF THE NEEDLE BEING LEFT IN THE PATIENT BY THE SURGEON.

  Patient problems: Foreign Body In Patient

  MAUDE report 12793559 ↗