NA 207.632Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982148209), received between Feb 13, 2018 and Apr 4, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionApr 4, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE THREAD OF A 4.0MM CANNULATED SCREW CAME OFF AS IT WAS BEING INSERTED INTO THE BONE. THIS HAPPENED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF AN ANKLE ON (B)(6) 2018. THE SURGEON WAS TRYING THE TORQUE FEATURE ON A NEW POWER DRILL WHEN THIS OCCURRED. FRAGMENTS WERE GENERATED FROM THE THREAD AND SOME OF THE FRAGMENTS WERE LEFT BEHIND IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO COMPLETE THE PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395655 ↗
• InjuryFeb 13, 2018Break; Device Operates Differently Than Expected; Unintended Movement; Break; Device Operates Differently Than Expected; Unintended Movement

  IT WAS REPORTED THAT DURING AN INITIAL REPAIR OF AN ANKLE FRACTURE, ONE (1) 4.0MM CANNULATED SHORT THREADED SCREW WOULD NOT HOLD ON TO THE BONE VERY WELL AND WAS LATER DISCOVERED TO BE CAUSED BY THE UNCOILING OF THREADS ON THE CANNULATED SCREW. THE PLAN DURING THE SURGERY WAS TO REPAIR THE ANKLE FRACTURE USING MULTIPLE UNKNOWN SCREWS WITH MULTIPLE UNKNOWN SCREWS IN THE FIBULA AND IMPLANTING TWO (2) 4.0MM CANNULATED SHORT THREADED SCREWS IN THE SUBCHONDRAL BONE OF THE DISTAL TIBIA FROM THE ANTERIOR TO POSTERIOR POSITION. THE SURGEON PRE-DRILLED FOR BOTH THESE 4.0 CANNULATED SCREWS AND ONE OF THEM WAS IMPLANTED WITHOUT ANY COMPLICATIONS. THE SURGEON HAD NOT DRILLED DEEP ENOUGH FOR THE SECOND 4.0 CANNULATED SCREW AND WHILE INSERTING IT INTO THE DRILLED HOLE, THE SCREW DID NOT THREAD WELL INTO THE BONE. IN AN INTRA-OPERATIVE X-RAY, THE SURGEON OBSERVED SMALL COIL LIKE METAL DEEP INSIDE THE BONE AND WAS NOT SURE WHAT IT WAS. THE SURGEON HAD TO EXPAND THE ORIGINAL INCISION TO REMOVE THE 4.0 CANNULATED SCREW OUT AND HAD TO SCOPE THE AREA TO REMOVE THE COIL LIKE METAL FRAGMENTS WHICH WERE LATER DISCOVERED TO BE THE THREADS FROM THE 4.0 CANNULATED SCREWS TO HAVE UNCOILED. SINCE THE FRAGMENT

  Patient problems: No Code Available

  MAUDE report 7268448 ↗