Cannulated Compression Headless Screw 04.334.440Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00819917024395), received between Apr 24, 2023 and Oct 21, 2024 — classified as 1 injury, 1 malfunction.

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

• MalfunctionOct 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THIS SUBMISSION IS FOR THE SECOND DEVICE ASSOCIATED WITH 3012966183-2024-00018. ADVERSE EVENT FROM THE CLINICAL STUDY: AT 9-MONTHS POST-OPERATIVE IMAGING DEMONSTRATED SCREW LOOSE, RADIOLUCENCY; THE SUBJECT WAS ORDERED A BONE GROWTH STIMULATOR AND TOE-OFF BRACE. AT 11-MONTHS POST-OPERATIVE SUBJECT CONTINUED TO HAVE PAIN WITH AMBULATION AND PLANNED TO CONTINUE TO USE BONE GROWTH STIMULATOR AND SIMULTANEOUSLY SCHEDULE SURGERY TO HAVE HARDWARE REMOVED IF NO IMPROVEMENT IS SEEN WITH BONE GROWTH STIMULATOR; IMAGING DEMONSTRATED THAT THE RADIOLUCENCY REMAINED VISIBLE HOWEVER NO NEW SIGNS OF LOOSENING. AT 12- MONTHS POST-OPERATIVE SUBJECT CONTINUED TO USE BONE GROWTH STIMULATOR WITH NO SIGNS OF INCREASED HEALING; IMAGING SHOWS RADIOLUCENCY REMAINED PRESENT. AT 13.5-MONTHS POST-OPERATIVE SUBJECT UNDERWENT HARDWARE REMOVAL SURGERY DUE TO THE NONUNION. ALL HARDWARE WAS REMOVED DURING THE PROCEDURE AND WAS REPLACED WITH A DIFFERENT BRAND'S SYSTEM. SUBJECT WAS TERMINATED FROM THE STUDY UPON REMOVAL OF HEADLESS SCREWS.

  Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Radiolucent Lines

  MAUDE report 20498367 ↗
• InjuryApr 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP AT THE TIME OF ORIF MEDIAL EPICONDYLE THE HEADLESS SCREW BROKE OFF IN PATIENT ON INSERTION. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE ACTION WAS TAKEN AS USED BROKEN SCREW REMOVAL SET TO RETRIEVE BROKEN HALF OF THE SCREW. INSERTED ANOTHER SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE FRAGMENTS GENERATED. THE FRAGMENT WAS DIFFICULT TO REMOVE, AND WE HAD TO USE BROKEN SCREW INSTRUMENTS TO RETRIEVE THE PIECE. THIS PART TOOK APPROXIMATELY 20 MIN. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED WHICH IS SCREW REMOVAL PROCESS, LARGER INCISION, MORE BONE REMOVAL, INCREASED TIME IN SURGERY, INCREASED TOURNIQUET TIME. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16796439 ↗