D-RAD SMART PACK 71158022Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556364598), received between Jul 27, 2020 and Oct 19, 2022 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Corroded” (8 reports).

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 9 most recent of 9 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 THE REMOVAL OF THE PLATE DUE TO CARPAL TUNNEL SYNDROME. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR EIGHT (8) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED COMPLICATION AND A DATE OF SURGERY FOR THE PLATE REMOVAL IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nerve Damage

  MAUDE report 15636078 ↗
• 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 15213819 ↗
• 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 15213807 ↗
• MalfunctionJun 23, 2021Corroded; Corroded

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED TRAUMA SURGERY, A "RUSTY" APPEARANCE WAS FOUND IN THE SURFACE OF THREE D-RAD SMART PACK 4H RIGHT WIDE PLATE ((B)(4)). A SURGICAL DELAY OF LESS THAN 30 MIN OCCURRED DUE TO THIS EVENT, AND THE PROCEDURE WAS CONCLUDED WITH A SMITH AND NEPHEW BACKUP RIGHT WIDE PLATE. NO PATIENT INJURY WAS REPORTED RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12052602 ↗
• MalfunctionJun 22, 2021Corroded; Corroded

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED TRAUMA SURGERY, A "RUSTY" APPEARANCE WAS FOUND IN THE SURFACE OF THREE D-RAD SMART PACK 4H RIGHT WIDE PLATE ((B)(4)). A SURGICAL DELAY OF LESS THAN 30 MIN OCCURRED DUE TO THIS EVENT, AND THE PROCEDURE WAS CONCLUDED WITH A SMITH AND NEPHEW BACKUP RIGHT WIDE PLATE. NO PATIENT INJURY WAS REPORTED RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046663 ↗
• MalfunctionJun 22, 2021Corroded; Corroded

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED TRAUMA SURGERY, A "RUSTY" APPEARANCE WAS FOUND IN THE SURFACE OF THREE D-RAD SMART PACK 4H RIGHT WIDE PLATE (CASE - (B)(4)). A SURGICAL DELAY OF LESS THAN 30 MIN OCCURRED DUE TO THIS EVENT, AND THE PROCEDURE WAS CONCLUDED WITH A SMITH AND NEPHEW BACKUP RIGHT WIDE PLATE. NO PATIENT INJURY WAS REPORTED RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046634 ↗
• MalfunctionApr 26, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING A SURGERY THE D-RAD SMART PACK 4H RIGHT WIDE PLATE HAD A SCREW DRIVER, DEPTH AND DRILL BITS WITH RUST ON THEM HENCE THE DEVICE WAS NOT STERILE. THIS HAPPENED EXTERNAL TO THE PATIENT THEREFORE WAS NOT INJURE INFRINGE TO THE PERSON. THIS CAUSE A CONSIDERABLE DELAY OF ONE HOUR TO PERFORM THE PROCEDURE. THE IMPLANTS WERE SENT FOR STERILIZATION AND RE-USED ON THE PATIENT. NO OTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729566 ↗
• MalfunctionFeb 28, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING SURGERY, IT WAS NOTICED THAT THE SCREWDRIVER IN THE STERILE KIT SHOWED TRACES OF RUST. THE PROCEDURE WAS COMPLETED USING ANOTHER SMITH & NEPHEW DEVICE WITH NO SURGICAL DELAY, AND NO INJURY TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11390981 ↗
• InjuryJul 27, 2020Corroded; Corroded

  IT WAS REPORTED THAT DURING INTRA-OP WHILE PERFORMING AN OPEN REDUCTION INTERNAL FIXATION OF DISTAL END RADIUS IT WAS FOUND OUT THAT SCREWDRIVER WAS ALREADY RUSTY. NO DELAY REPORTED. THE SURGICAL PROCEDURE WAS COMPLETED BY USING THE ORIGINAL DEVICE BECAUSE WASN'T OTHER SUITABLE INSTRUMENT TO PERFORM DURING THE SURGICAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10330390 ↗

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-1855-2017 · Mar 9, 2017 · Terminated
  D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
• 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