NA 358.697Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982196842), received between Jul 3, 2019 and Jul 3, 2019 — classified as 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN SURGERY WITH AN EXPERT HUMERAL NAIL, THE SURGEON COULD NOT CONNECT THE COUPLING SCREW WITH AN UNKNOWN SPIRAL BLADE AND AN INSERTER SPIRAL BLADE. THEN, THE SURGEON TRIED AGAIN USING ANOTHER SPIRAL BLADE HOWEVER, THE PROBLEM WAS NOT IMPROVED. CONSEQUENTLY, THE THREADED PART OF THE COUPLING SCREW FOR SPIRAL BLADE LOOKED DAMAGED AND IT COULD NOT BE INSERTED UNTIL AN APPROPRIATE POSITION. EVENTUALLY, THE SURGEON CONNECTED BY ROTATING THE COUPLING SCREW FORCIBLY AND INSERTED THE SPIRAL BLADE SUCCESSFULLY. THERE WAS A LESS THAN 30 MINUTES SURGICAL DELAY WITH NO ADVERSE CONSEQUENCE REPORTED TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN SPIRAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2); INSERTER FOR SPIRAL BLADE (PART# 358.696, LOT# UNKNOWN, QUANTITY 1); UNKNOWN EXPERT HUMERAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8760196 ↗