Arthrex® AR-4157-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867193932), received between Oct 12, 2016 and Jul 14, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A HAMMER TOE REPAIR PROCEDURE, THE SURGEON DRILLED TO APPROPRIATE DEPTH AND WENT TO INSERT THE 24MM RETROFUSION SCREW (LOT: 10052898), AS THE SURGEON BEGAN TO TORQUE, THE HEAD OF THE SCREW SNAPPED OFF. THE PROXIMAL PORTION OF THE SCREW WAS LEFT IN THE PATIENT'S BONE SITTING PROUD IN THE JOINT. THE SURGEON CLEANED OUT AROUND THE SHAFT OF THE SCREW AND USED A NEEDLE DRIVER AS WELL AS PLIERS TO TRY AND GET A GRIP OF THE SCREW HOWEVER, WAS UNSUCCESSFUL AT RETRIEVING THE FRAGMENT. THE SURGEON MOVED ON AND IMPLANTED TWO K-WIRES TO PIN THE JOINT IN PLACE. 15-20 MIN DELAY IN CASE. PATIENT IS A (B)(6) Y/O MALE. THE SURGEON HAS NOT YET STATED WHETHER OR NOT HE WOULD LIKE TO GO IN AT A LATER DATE TO TRY AND RETRIEVE THE SCREW. FOLLOW-UP INVESTIGATION: AS OF TODAY THE SURGEON IS NOT PLANNING ON RETRIEVING THE SCREW FRAGMENT FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6714756 ↗
• InjuryOct 12, 2016Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT DURING A SECOND AND THIRD PIP FUSION CASE, THE AR-4157-24 RETROFUSION SCREW, 24MM BROKE WHILE ATTEMPTING TO INSERT IN THE SECOND PIP JOINT. BONY PREP WAS FOLLOWED PER SURGICAL TECHNIQUE. THE SCREW WAS ADVANCED IN THE PROXIMAL PHALANX AND WAS UNABLE TO ADVANCE FURTHER THAN 2/3 OF PROXIMAL THREADS BEING IN THE IM CANAL. K WIRE WAS TAKEN CIRCUMFERENTIALLY AROUND SCREW IN ATTEMPTS TO SOFTEN SURROUNDING BONE AND REMOVE SCREW BUT WAS UNSUCCESSFUL. SINCE SCREW COULD NOT BE REMOVED, ATTEMPTS WERE MADE TO COMPLETE THE INSERTION AND THE DISTAL ASPECT OF THE SCREW BROKE AT THE SMOOTH JUNCTION. THE DISTAL ASPECT OF THE SCREW WAS LEFT IN THE PATIENT BUT THE PROXIMAL PORTION WAS RETRIEVED. THE SECOND PIP FUSION WAS COMPLETED WITH A SOFT TISSUE REATTACHMENT ONLY AND THE THIRD PIP FUSION WAS COMPLETED WITH A K-WIRE. IT WAS NOTED THAT THE BONE WAS PREPARED USING AR-4157DS KIT AND THE DRIVER FROM THE AR-4157DS WAS USED FOR THE IMPLANT SCREW. PATIENT WAS A (B)(6) MALE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6020451 ↗