DHHS 338.346Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982193414), received between Sep 13, 2019 and Sep 13, 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.

• MalfunctionSep 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING FIELD INSPECTION THE FOLLOWING ITEMS WERE FOUND BROKEN: ONE (1) CABLE TENSIONER DEVICE HAS SOMETHING STUCK INSIDE OF IT PREVENTING PROPER USE, TOP CLIP OF THE TWO (2) LOCKING COMPRESSION PLATE DYNAMIC HELICAL HIP SYSTEM INSERTER GUIDE WERE BROKEN PREVENTING PROPER USE, ONE (1) LOCKING COMPRESSION PLATE DYNAMIC HELICAL HIP SYSTEM INSERTER SHAFT IS NOT ROUND THEREFORE SCREW CANNOT PASS THROUGH INSTRUMENT, THE HANDLE OF ONE (1) SCREWDRIVER T15 CRACKED, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER SHOULD HAVE ROUND TIP THEREFORE SCREWS DOES NOT FIT, HANDLE OF THE ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE WAS BUSTED, AND THE TIP OF THE ONE (1) DEPTH GAUGE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 FOR 5 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9030788 ↗