NA 214606Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705003891), received between Mar 29, 2017 and Mar 29, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Open or Close” (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.

• InjuryMar 29, 2017Difficult to Open or Close; Difficult to Open or Close

  AFFILIATE REPORTED VIA EMAIL DURING ARTHROSCOPIC ROTATOR CUFF REPAIR, SUTURE ANCHOR BECAME DISLODGED (FROM OSTEOPENIC BONE). DURING ATTEMPTS BY SURGEON TO REMOVE THE LOOSE ANCHOR (ARTHROSCOPICALLY), BOTH DEVICES, MENTIONED ABOVE, WERE DAMAGED AND FAILED TO OPEN / CLOSE EFFECTIVELY. NEED REPLACING. ALTERNATE DEVICE (FROM COMPETITOR TRAY OF SHOULDER INSTRUMENTS) WERE USED TO EVENTUALLY REMOVE ANCHOR. TWO MINUTES DELAY. NO ADVERSE EVENT TO PATIENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 3-3-2017 THE ORIGINAL BONE HOLE WAS NOT USED TO COMPLETE THE PROCEDURE. THE BONE HOLE LEFT UNFILLED. SURGEON HAPPY WITH REPAIR WITH OTHER ANCHORS USED. LOT NUMBERS ARE AS FOLLOWS: RATCHETED GRASPER - (214606) - 16J02. SUTURE MANIPULATOR - (214626) - 13E01 . ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 3-20-2017. NO PRODUCT INFORMATION HAD BEEN PROVIDED IN RELATION TO THE ANCHOR.

  Patient problems: Tissue Damage

  MAUDE report 6445067 ↗