D-RAD SMART PACK 71158020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556364499), received between Aug 11, 2022 and Oct 19, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Corroded” (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 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.

• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT REQUIRED AN UNPLANNED REVISION ON AN UNKNOWN DATE DUE TO NONUNION OF THE FRACTURE. THE PATIENT ACHIEVED A RADIOGRAPHIC UNION THREE (3) MONTHS POSTOPERATIVELY. ADDITIONAL DETAILS REGARDING THIS INTERVENTION AND THE PATIENT'S CURRENT HEALTH STATUS ARE NOT AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Malunion of Bone; Nonunion/Delayed-union Bone Fracture; Swelling/ Edema

  MAUDE report 15636313 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT SUSTAINED THE NONUNION OF THE FRACTURE ALONG WITH PAIN AND AN UNEXPECTED DECREASE IN RANGE OF MOTION. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR EIGHT (8) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOMS IS NOT KNOWN. THE PATIENT'S OUTCOME, AS WELL AS ANY MEASURES TAKEN TO RESOLVE THESE COMPLICATIONS REMAIN UNKNOWN.

  Patient problems: Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15635943 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED THE RUPTURE OF THE FLEXOR POLLICIS LONGUS (FPL) TENDON WHICH REQUIRED THE PLATE REMOVAL ON AN UNKNOWN DATE. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 15635205 ↗
• MalfunctionAug 11, 2022Corroded; Corroded

  IT WAS REPORTED THAT, WHILE SETTING UP FOR AN INTERNAL FIXATION, THE SCREWDRIVERS OF THE FOLLOWING PLATE KITS WERE NOTICED WITH RUST: D-RAD SMART PACK 4H LEFT STANDARD PLATE, D-RAD SMART PACK 4H LEFT WIDE PLATE, D-RAD SMART PACK 4H RIGHT STANDARD PLATE AND TWO D-RAD SMART PACK 4H RIGHT WIDE PLATES. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE SO SURGERY STARTED ON TIME. THE PATIENT WAS NOT AFFECTED BY THE FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213739 ↗

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