D-RAD SMART PACK 74692422Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556396346), received between May 20, 2021 and May 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K132296, K210837, K213126); they may or may not involve this specific model.

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

• MalfunctionMay 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN OSTEOSYNTHESIS SURGERY THE D-RAD TI 2.4MM X 22MM LCK SCR S-T THE SCREW DID NOT LOCK, SO THERE WAS A FAILURE TO INSERT THE SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860136 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132296, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2018 · Mar 7, 2018 · Terminated
  D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERI
• Z-1856-2017 · Mar 9, 2017 · Terminated
  D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
• Z-1857-2017 · Mar 9, 2017 · Terminated
  D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM
• Z-1855-2017 · Mar 9, 2017 · Terminated
  D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic