PHALINX 45A01003Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889797102155), received between Dec 4, 2023 and Jul 22, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Positioning Failure; Separation Failure; Positioning Failure; Separation Failure

  IT WAS REPORTED THAT THE DURING A LAB THE PHALINX IMPLANT WORKED AS INTENDED, HOWEVER THE INSERTER WAS ¿STICKIER¿ AND GRASPED THE IMPLANT VERY TIGHTLY AND IT WAS VERY HARD TO REMOVE IT FROM THE HANDLE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800763 ↗
• MalfunctionJul 22, 2024Positioning Failure; Separation Failure; Mechanical Jam; Positioning Failure; Separation Failure; Mechanical Jam

  IT WAS REPORTED THAT THE IMPLANT INSERTER WILL NOT RELEASE THE IMPLANT ONCE IMPLANTED. THE IMPLANT IS THEN RIPPED OUT OF THE MIDDLE PHALANX WHEN THE SURGEON TRIES TO BACK THE INSERTER OUT. THE SURGEON USED AN ALICE TO SCREW IN THE IMPLANT. THERE WAS A 30 MINUTE SURGICAL DELAY. THERE IS NO ADVERSE CONSEQUENCE TO THE PATIENT BUT THERE IS A CONCERN THAT THE IMPLANT WILL FALL OUT AND LEAD TO A NON-UNION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19797091 ↗
• MalfunctionJul 11, 2024Positioning Failure; Separation Failure; Mechanical Jam; Positioning Failure; Separation Failure; Mechanical Jam

  IT WAS REPORTED THAT THE SCREW WOULD NOT DETACH FROM THE PRE-LOADED INSERTER AFTER IMPLANTING IN THE PATIENT. THE DOCTOR UNSCREWED THE IMPLANT FROM THE PATIENT AND HAD TO USE A HEMOSTAT TO GET THE IMPLANT OUT OF THE INSERTER. IT TOOK HIM SEVERAL TRIES TO REMOVE THE IMPLANT FROM THE INSERTER AS IT WOULD NOT BUDGE. A METAL INSERTER WAS USED TO INSERT THE SCREW WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19723102 ↗
• InjuryDec 4, 2023Positioning Failure; Unstable; Separation Failure; Mechanical Jam; Positioning Failure; Unstable; Separation Failure; Mechanical Jam

  THE PATIENT HAD HAMMERTOES ON 2ND & 3RD DIGITS THAT NEEDED FIXATION. IT WAS REPORTED THAT THE IMPLANTS DID NOT WANT TO COME OFF OF THE HANDLES AND THE DRILL BITS DID NOT WANT TO DETACH FROM THE HANDLES EITHER TO DRILL USING POWER. IT TOOK APPROXIMATELY 10-15 MINUTES LONGER DUE TO HAVING TO PRY THE IMPLANT AND DRILL FROM THEIR HANDLES. AND THE IMPLANT WAS PUT IN TO THE MIDDLE PHALANX THREE TIMES ON THE 2ND DIGIT AND IT PULLED OUT WITH THE HANDLE EACH TIME. IT WAS LOOSE AND SECURED WITH K WIRE. THE 3RD DIGIT WAS IMPLANTED WITHOUT THE USE OF THE HANDLE IN THE KIT AND WENT SMOOTHLY MINUS ISSUES REMOVING THE IMPLANT FROM THE HANDLE. BONE QUALITY IN PATIENT APPEARED TO BE GOOD AS HE HAD TO USE SOME EFFORT WHEN DRILLING USING POWER. WHEN THE IMPLANT WAS SCREWED INTO THE MIDDLE PHALANX AND FULLY SEATED HE FELT THAT THERE WAS A GOOD AMOUNT OF BITE, BUT WHEN THE HANDLE WAS PULLED BACK IT WOULD NOT RELEASE THE IMPLANT. THIS CAUSED THE IMPLANT TO PULL OUT OF THE MIDDLE PHALANX AND IT REMOVED BONE WITH IT. THIS WAS ATTEMPTED THREE TIMES BEFORE PULLING THE IMPLANT OUT OF THE HANDLE WHICH REQUIRED SOME FORCE AND THEN IT WAS INSERTED USING FORCEPS. DEVICE DID NOT APPEAR TO BE BROKEN AND NO OTHER C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263497 ↗