NA 71128692Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010544537), received between Mar 15, 2021 and Mar 15, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Connection 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 18, 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 15, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, FIXATION STAPLE W/SPIKE 12MMX23MM SMALL WAS LOADED APPROPRIATELY ONTO STAPLE DRIVER, AND WHILE IT WAS BEING INSERTED, THE STAPLE SPLAYED TO THE SIDES AND DID NOT ENTER THE BONE APPROPRIATELY. THE SURGEON REMOVED IT, AND ON INSPECTION, IT WAS NOTICED THAT THE END OF THE STAPLE HAD WIDENED. SURGEON WAS ABLE TO BEND AND MANIPULATE STAPLE BACK INTO SHAPE WITH MINIMAL EFFORT. A BACKUP DEVICE FROM SMITH AND NEPHEW WAS USED INSTEAD TO COMPLETE THE PROCEDURE. A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. THERE WAS NO INJURY TO PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479709 ↗