NA 358.696Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982196835), received between Dec 20, 2018 and Mar 26, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MARCH 02, 2020, A SPIRAL BLADE INSERTER WOULD NOT PASS THROUGH SPIRAL BLADE AIMING ARM. PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS A SURGICAL DELAY OF 1-2 MINUTES. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX (PART 03.010.055, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884486 ↗
• MalfunctionApr 8, 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 PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO PUT THE SPIRAL BLADE INSERTER (WITH THE SPIRAL BLADE ATTACHED) THROUGH THE SPIRAL BLADE HOLE IN THE AIMING ARM. THE BLADE WENT THROUGH THE HOLE BUT THE INSERTER WOULD NOT. THE DIAMETER OF THE INSERTER WAS TOO WIDE TO FIT INSIDE THE AIMING ARM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN SPIRAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8493907 ↗
• MalfunctionFeb 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A HUMERAL EXPERT NAIL SYSTEM PROCEDURE ON (B)(6) 2019, THE SPIRAL BLADE INSERTER WOULD NOT FIT THROUGH THE AIMING ARM. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8322733 ↗
• MalfunctionJan 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: UNKNOWN - GUIDES/SLEEVES/AIMING: AIMING ARM (PART #UNKNOWN, LOT # UNKNOWN, QUANTITY # 1).

  Patient problems: No Patient Involvement

  MAUDE report 8286692 ↗
• InjuryDec 20, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE LEFT HUMERAL DIAPHYSEAL FRACTURE WAS PERFORMED WITH AN EXPERT HUMERAL NAILING SYSTEM. THE SURGEON TRIED TO INSERT THE SPIRAL BLADE IN ACCORDANCE WITH THE SURGICAL TECHNIQUE BUT THE BLADE INTERFERED WITH THE ANTERIOR SIDE OF THE NAIL. THIS WAS CONFIRMED BY X-RAY ANALYSIS. THE SURGEON REMOVED THE BLADE FROM THE PATIENT AND FOUND IT WAS BROKEN. ANOTHER BLADE OF DIFFERENT LENGTH WAS INSERTED SUCCESSFULLY BY ADJUSTING THE INSERTER TO FACE THE ANTERIOR WITHIN THE AIMING ARM. THE SURGERY WAS DELAYED LESS THAN 30 MINUTES. ADVERSE CONSEQUENCE WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS . THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8185831 ↗