NA 02.214.115Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982055491), received between May 14, 2020 and May 14, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE THIRD PROXIMAL PHALANX, THE 3 1.5MM CORTEX SCREW SELF TAPPING WITH STARDRIVE RECESS 15MM HEADS BROKE OFF WHILE INSERTING OR REMOVING THE SCREWS. SURGEON ATTEMPTED TO RETRIEVE THE SCREWS AND THE SCREW SHAFTS BUT WAS UNSUCCESSFUL. THERE WAS A LESS THAN OPTIMAL FIXATION DUE TO BROKEN SCREW HEADS AND LONG SCREW WHICH MAY CAUSE IRRITATION WAS UNABLE TO BE RETRIEVED. SURGEON WAS UNABLE TO REMOVE SCREW SHAFTS WITHOUT EXCESSIVE DISSECTION. SCREW SHAFTS WERE NOT REMOVED. THERE WERE FRAGMENTS GENERATED. THERE WAS A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES 3 DEVICES. THIS REPORT IS FOR 1 1.5MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 15MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available; Tissue Damage

  MAUDE report 10058973 ↗
• InjuryMay 14, 2020Break; Break

  CONCOMITANT DEVICE REPORTED: SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: Foreign Body In Patient; No Code Available; Tissue Damage

  MAUDE report 10058964 ↗
• InjuryMay 14, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE THIRD PROXIMAL PHALANX, THE THREE (3) 1.5MM CORTEX SCREW SELF TAPPING WITH STARDRIVE RECESS 15MM HEADS BROKE OFF WHILE INSERTING OR REMOVING THE SCREWS. SURGEON ATTEMPTED TO RETRIEVE THE SCREWS AND THE SCREW SHAFTS BUT WAS UNSUCCESSFUL. THERE WAS A LESS THAN OPTIMAL FIXATION DUE TO BROKEN SCREW HEADS AND LONG SCREW WHICH MAY CAUSE IRRITATION WAS UNABLE TO BE RETRIEVED. SURGEON WAS UNABLE TO REMOVE SCREW SHAFTS WITHOUT EXCESSIVE DISSECTION. SCREW SHAFTS WERE NOT REMOVED. THERE WERE FRAGMENTS GENERATED. THERE WAS A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES 3 DEVICES. THIS REPORT IS 1 1.5MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 15MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available; Tissue Damage

  MAUDE report 10058963 ↗