MAUDE Adverse Event Report: SMITH & NEPHEW, INC. D-RAD SMART PACK 4H LEFT WIDE PLATE; PLATE, FIXATION, BONE

Catalog Number 71158020

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the drad packs were opened in theatre.The devices were found with rust on the screwdriver handles.The surgeon used a competitor device to finish the surgery.No further information available yet.

Manufacturer Narrative

The devices, used in treatment, was returned for evaluation.A visual inspection was performed and confirmed the stated failure.The metal tips of the drivers showed signs of rust.The devices were manufactured in 2014 and 2015.Upon review of the returned parts it was noted that the d-rad t7 capture driver hex bit is corroded while still packaged.Nothing noted in the dhr or internal operations that would indicate this issue to be caused internally.Our lab noted: the presence of rust in several sections of the devices.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A root cause could not be determined with the information provided.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: D-RAD SMART PACK 4H LEFT WIDE PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9147996
• MDR Text Key: 161002891
• Report Number: 1020279-2019-03541
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K132296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71158020
• Device Lot Number: 15EM18790
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1