OsteoMed 400-3703-SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842528104187), received between Jul 10, 2019 and Oct 1, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2021Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2021, DR. (B)(6) POSTED A CASE FOR AN AKIN OSTEOTOMY. AFTER PREPARING THE BONE AND DRILLING FOR THE STAPLE, DR. LE WAS READY TO USE A 10X10MM INSTAFIX STAPLE. AS HE WAS ATTEMPTING TO USE THE FIRST STAPLE, THE DOCTOR NOTICED THE STAPLE (ITEM #: 400-3703-SP, LOT # (B)(4), EXP DATE 4/27/2026) LEG WAS BENT INWARD SIGNIFICANTLY. THE STAPLE WOULD NOT FIT IN THE DRILL HOLES AS WELL AS THE DRILL GUIDE HOLES, CONFIRMING THE SIGNIFICANT BEND IN THE STAPLE. DR. (B)(6) DECIDED TO ATTEMPT USING A SECOND STAPLE (ITEM #: 400-3703-SP, LOT # (B)(4), EXP DATE 4/27/2026). AFTER INSPECTING THE SECOND STAPLE THROUGH THE STERILE PACKAGING, HE CONFIRMED THAT THE STAPLE LEG WAS BENT INWARD SIGNIFICANTLY, SIMILAR TO THE FIRST STAPLE THAT HE ATTEMPTED TO USE. THIS STAPLE WAS LEFT IN ITS STERILE PACKAGING. DR. (B)(6) DECIDED TO TRY A FINAL STAPLE THAT HAD A DIFFERENT LOT NUMBER (ITEM #: 400-3703-SP, LOT # (B)(4), EXP DATE 10/23/2024). THIS THIRD STAPLE HAD A LEG BENT INWARD, BUT NOT AS SEVERELY AS THE PREVIOUS TWO. DR. (B)(6) DECIDED TO REDRILL WITHOUT THE DRILL GUIDE TO ACCOUNT FOR THE SLIGHT BEND IN THE STAPLE. AS HE ATTEMPTED TO INSERT THE THIRD STAPLE, HE COULD NOT FULLY INSERT THE STAPLE BECAU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565514 ↗
• MalfunctionOct 1, 2021Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2021, DR. (B)(6) POSTED A CASE FOR AN AKIN OSTEOTOMY. AFTER PREPARING THE BONE AND DRILLING FOR THE STAPLE, DR. (B)(6) WAS READY TO USE A 10X10MM INSTAFIX STAPLE. AS HE WAS ATTEMPTING TO USE THE FIRST STAPLE, THE DOCTOR NOTICED THE STAPLE (ITEM #: 400-3703-SP, LOT # 20620972102, EXP DATE 4/27/2026) LEG WAS BENT INWARD SIGNIFICANTLY. THE STAPLE WOULD NOT FIT IN THE DRILL HOLES AS WELL AS THE DRILL GUIDE HOLES, CONFIRMING THE SIGNIFICANT BEND IN THE STAPLE. DR. (B)(6) DECIDED TO ATTEMPT USING A SECOND STAPLE (ITEM #: 400-3703-SP, LOT # (B)(4), EXP DATE 4/27/2026). AFTER INSPECTING THE SECOND STAPLE THROUGH THE STERILE PACKAGING, HE CONFIRMED THAT THE STAPLE LEG WAS BENT INWARD SIGNIFICANTLY, SIMILAR TO THE FIRST STAPLE THAT HE ATTEMPTED TO USE. THIS STAPLE WAS LEFT IN ITS STERILE PACKAGING. DR. (B)(6) DECIDED TO TRY A FINAL STAPLE THAT HAD A DIFFERENT LOT NUMBER (ITEM #: 400-3703-SP, LOT # (B)(4), EXP DATE 10/23/2024). THIS THIRD STAPLE HAD A LEG BENT INWARD, BUT NOT AS SEVERELY AS THE PREVIOUS TWO. DR. (B)(6) DECIDED TO REDRILL WITHOUT THE DRILL GUIDE TO ACCOUNT FOR THE SLIGHT BEND IN THE STAPLE. AS HE ATTEMPTED TO INSERT THE THIRD STAPLE, HE COULD NOT FULLY INSERT THE STA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565465 ↗
• MalfunctionJul 10, 2019Difficult to Remove

  ON 06/20/2019 OSTEOMED WAS NOTIFIED OF AN ADVERSE EVENT RELATED TO THE INSTAFIX STAPLE IMPLANT KIT, 10 X 10 MM. PER OUR REPRESENTATIVE, THE PHYSICIAN OPENED JOINT AND RONGEURED OFF DISTAL AND PROXIMAL PORTION OF JOINT AND STABILIZED WITH K-WIRE. WHEN PUTTING IN THE K-WIRE, PART OF THE BONE FRACTURED OFF. HE THEN DRILLED AND PLACED AN 8X8 INSTAFIX STAPLE. HE DECIDED TO PLACE A 10X10 STAPLE. HE DRILL AND BEGAN TO PLACE THE STAPLE. HE STRUGGLED TO REMOVE 10X10 STAPLE FROM INSERTER, DURING THIS TIME PATIENT'S BONE FRACTURED. HE CONSIDERED REMOVING THE STAPLE AND DECIDED AGAINST IT. HE THEN ADDED A 2ND 10X10 STAPLE, ALTHOUGH HE STRUGGLED TO GET THE STAPLE OFF THE INSERTER AGAIN, HE WAS ABLE TO DO IT WITHOUT FURTHER INJURY. HE LEFT ALL 3 STAPLES INTACT AND FELT THAT HE HAD REASONABLE COMPRESSION.

  Patient problems: Bone Fracture(s)

  MAUDE report 8776407 ↗