NA 357.378Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982196095), received between Oct 22, 2018 and Mar 26, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2021Break; Break

  IT WAS REPORTED THAT, THE HELICAL BLADE EXTRACTOR COLD WELDED WHILE USING FOR EXTRACTION OF HELICAL BLADE, INSERTED DRILL SLEEVES BROKE OFF AND PERIARTICULAR PROX HUMERUS PLATE LOCKING HOLE WAS STRIPPED AFTER INSERTING CORTICAL SCREW. SURGICAL DELAY AND PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HELICAL BLADE EXTRACTOR. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576128 ↗
• MalfunctionDec 11, 2019Mechanical Problem; Component Missing; Material Twisted/Bent; Mechanical Problem; Component Missing; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE HELICAL BLADE EXTRACTOR WAS FOUND NOT FUNCTIONING DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. DURING MANUFACTURER'S INVESTIGATION ON (B)(6) 2019 IT WAS OBSERVED THAT INTERNAL THREAD PORTION OF THE BLADE INTERFACE SLEEVE AT THE PROXIMAL SIDE WAS FOUND TO BE STRIPPED/WORN WHICH CAN ALSO IMPACT THE FUNCTIONALITY OF THE DEVICE. THIS REPORT IS FOR ONE (1) HELICAL BLADE EXTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9454218 ↗
• MalfunctionOct 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DAMAGED INSTRUMENT WOULD NOT ATTACH PROPERLY DURING SURGERY. NO FURTHER PATIENT INFORMATION. THIS REPORT IS FOR ONE (1) HELICAL BLADE EXTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9184881 ↗
• MalfunctionOct 22, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING REMOVAL OF A TROCHANTERIC FIXATION NAIL (TFN), THE HELICAL BLADE HAS BECOME STUCK ON THE CONNECTING SCREW AND EXTRACTION INSTRUMENT. THERE WAS NO INFORMATION GIVEN ON WHY THE IMPLANT WAS BEING REMOVED OR IF ANYTHING WAS IMPLANTED IN PLACE OF IT. THE CASE WAS ABLE TO CONTINUE AS THE BLADE HAD BEEN REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS FINE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) HELICAL BLADE EXTRACTOR. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7993329 ↗