SALVATION SMN10008Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840420194817), received between May 19, 2021 and Jun 28, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE MIDFOOT NAIL ADAPTER BROKE OFF DURING THE PROCEDURE. THE PIECE THAT BROKE WAS STILL ATTACHED TO THE MIDFOOT NAIL. WHEN REMOVING THE MIDFOOT NAIL HOLDER FROM THE MIDFOOT NAIL AFTER IMPLANTATION, THAT IS WHEN IT WAS NOTED THAT THE ITEM BROKE. DEBRIS WAS RETAINED IN THE IM CANAL OF THE METATARSAL. IT DID NOT IMPACT ANYTHING AND THE SURGEON WAS NOT CONCERNED WITH IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19639154 ↗
• MalfunctionApr 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED VIA A MEDWATCH FORM THAT THE SURGEON USED DEVICE TO PLACE AN 80MM NAIL INTO PATIENT'S LEFT CALCANEUS. ADAPTER BROKE OFF INTO TWO PIECES INTO PATIENT WOUND. SURGEON USED A SECOND DEVICE OF SAME KIND, IT WAS BROKE INTO 1 PIECE. ATTEMPTS TO REMOVE 3 BROKEN PIECES, ONLY ABLE TO REMOVE 1 OF 3 PIECES, BROKEN PIECES LEFT IN THE PATIENT. RISK OUTWEIGHED THE BENEFITS OF REMOVAL. PATIENT WAS MADE AWARE OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14115583 ↗
• MalfunctionApr 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED VIA A MEDWATCH FORM THAT THE SURGEON USED DEVICE TO PLACE AN 80MM NAIL INTO PATIENT'S LEFT CALCANEUS. ADAPTER BROKE OFF INTO TWO PIECES INTO PATIENT WOUND. SURGEON USED A SECOND DEVICE OF SAME KIND, IT WAS BROKE INTO 1 PIECE. ATTEMPTS TO REMOVE 3 BROKEN PIECES, ONLY ABLE TO REMOVE 1 OF 3 PIECES, BROKEN PIECES LEFT IN THE PATIENT. RISK OUTWEIGHED THE BENEFITS OF REMOVAL. PATIENT WAS MADE AWARE OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14115574 ↗
• MalfunctionJan 24, 2022Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation

  THE MIDFOOT NAIL WAS SUCCESSFULLY ATTACHED TO THE CONNECTOR AND IMPLANTED. THE SURGEON FELT THE HANDLE "SNAP" ON HIS FINAL TURN. IT WAS THEN REALIZED THE CONNECTOR NIPPLES/WINGS BROKE OFF AND THE CONNECTOR WAS REMOVED FROM THE NAIL. THE SURGEON COULD NOT RETRIEVE THE SMALL METAL FRAGMENTS . THE SURGEON SUCCESSFULLY COMPRESSED THE NAIL AND CLOSED WITHOUT ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 13338174 ↗
• MalfunctionMay 19, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING INSERTION OF THE MIDFOOT NAIL, IT WAS NOTED BY THE SURGEON THAT IMPLANT HAD BEEN DRIVEN SLIGHTLY BEYOND THE IDEAL POSITION IN SITU. WHEN AN ATTEMPT WAS MADE TO TURN THE DRIVER HANDLE COUNTER-CLOCKWISE TO REVERSE THE NAIL, THE SURGEON FELT THE IMPLANT HOLDER ASSEMBLY GIVE WAY AND FAIL TO ADEQUATELY ENGAGE THE IMPLANT. UPON REMOVAL OF THE FIRST IMPLANT HOLDER ASSEMBLY FROM THE IMPLANTED NAIL, IT WAS NOTED THAT THE TABS WHICH INTERFACE WITH THE DISTAL END OF THE NAIL HAD BOTH SHEARED FROM THE HOLDER ASSEMBLY. THOSE FRAGMENTS WERE EASILY VISUALIZED AND RETRIEVED FROM THE DRILL CANAL BY THE SURGEON. A SECOND IMPLANT HOLDER ASSEMBLY WAS ATTACHED SECURELY TO THE IMPLANT, AND A SECOND ATTEMPT TO REVERSE THE TRAJECTORY OF THE IMPLANT WAS MADE, BUT UNSUCCESSFUL. THE SECOND IMPLANT HOLDER ASSEMBLY HAD FAILED IN THE SAME MANNER AS THE FIRST. AGAIN THE SHEARED TAB FRAGMENTS WERE EASILY VISUALIZED AND RETRIEVED FROM THE OPEN DRILL CANAL BY THE SURGEON. THERE WAS NOT A THIRD IMPLANT HOLDER ASSEMBLY AVAILABLE TO USE, SO THE SURGEON DETERMINED THAT HE COULD UTILIZE ALTERNATE INSTRUMENTATION (A NARROW OSTEOTOME AND PLIERS) TO ACT AS A SUBSTITUTE DRIVER TO ENGAGE THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852223 ↗
• MalfunctionMay 19, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING INSERTION OF THE MIDFOOT NAIL, IT WAS NOTED BY THE SURGEON THAT IMPLANT HAD BEEN DRIVEN SLIGHTLY BEYOND THE IDEAL POSITION IN SITU. WHEN AN ATTEMPT WAS MADE TO TURN THE DRIVER HANDLE COUNTER-CLOCKWISE TO REVERSE THE NAIL, THE SURGEON FELT THE IMPLANT HOLDER ASSEMBLY GIVE WAY AND FAIL TO ADEQUATELY ENGAGE THE IMPLANT. UPON REMOVAL OF THE FIRST IMPLANT HOLDER ASSEMBLY FROM THE IMPLANTED NAIL, IT WAS NOTED THAT THE TABS WHICH INTERFACE WITH THE DISTAL END OF THE NAIL HAD BOTH SHEARED FROM THE HOLDER ASSEMBLY. THOSE FRAGMENTS WERE EASILY VISUALIZED AND RETRIEVED FROM THE DRILL CANAL BY THE SURGEON. A SECOND IMPLANT HOLDER ASSEMBLY WAS ATTACHED SECURELY TO THE IMPLANT, AND A SECOND ATTEMPT TO REVERSE THE TRAJECTORY OF THE IMPLANT WAS MADE, BUT UNSUCCESSFUL. THE SECOND IMPLANT HOLDER ASSEMBLY HAD FAILED IN THE SAME MANNER AS THE FIRST. AGAIN THE SHEARED TAB FRAGMENTS WERE EASILY VISUALIZED AND RETRIEVED FROM THE OPEN DRILL CANAL BY THE SURGEON. THERE WAS NOT A THIRD IMPLANT HOLDER ASSEMBLY AVAILABLE TO USE, SO THE SURGEON DETERMINED THAT HE COULD UTILIZE ALTERNATE INSTRUMENTATION (A NARROW OSTEOTOME AND PLIERS) TO ACT AS A SUBSTITUTE DRIVER TO ENGAGE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852221 ↗