NA 214.550Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982154217), received between Jun 22, 2018 and Oct 12, 2021 — classified as 1 injury, 2 malfunctions.

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.

• InjuryOct 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, TUBERCLE OSTEOTOMY WAS PERFORMED WITH A 6.5 PARTIALLY THREADED CANNULATED SCREW AND A 4.5 PARTIALLY THREADED CANNULATED SCREW. ON AN UNKNOWN DATE IN (B)(6) 2021 THE PATIENT CAME BACK INTO OFFICE AND IT WAS IDENTIFIED THAT BOTH SCREWS ARE BROKEN. THERE ARE NO PLANS AS OF NOW TO BRING PATIENT BACK FOR PROCEDURE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 4.5 CANNULATED SCREW PARTIALLY THRD/50. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12617343 ↗
• MalfunctionAug 26, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CANNULATED SCREW THREADS STRIPPED OFF AND UNRAVELED IN A PATIENT DURING INSERTION ON THE POWER SCREWDRIVER. FRAGMENTS WERE GENERATED AND WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 4.5MM CANNULATED SCREW PARTIALLY THREADED/50MM. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454902 ↗
• MalfunctionJun 22, 2018Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A CAPITULUM FRACTURE ON (B)(6) 2018, THE SURGEON WAS USING A HEXAGONAL SCREWDRIVER TO INSERT THE CANNULATED SCREW WHEN THE SCREW BROKE AT THE THREAD/SHAFT JUNCTION. THE SCREW FRAGMENTED WHEN IT BROKE. THE SURGEON RETRIEVED THE LARGER PIECES OF THE SCREW, HOWEVER, THE SMALLER FRAGMENTS COULD NOT BE RETRIEVED AND WERE VISIBLE UNDER FLUOROSCOPY. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY, WITH A REPORTED DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES. PATIENT STATUS IS STABLE. CONCOMITANT DEVICE: CANNULATED 3.5MM HEXAGONAL SCREWDRIVER (PART: 314.20, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 4.5MM CANNULATED SCREW PARTIALLY THREADED/50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7630733 ↗