MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA IMPLANT; NAIL, FIXATION, BONE

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Event Description

It was reported that during surgery a set of the d-rad system, which was supposed to be sterile, had a rusted hexagonal screwdriver when it was opened.Delay greater than 30 min while the backup device was found to complete the procedure.No injury to patient.

Manufacturer Narrative

H10: h6: the devices, intended for use in treatment, were not returned for evaluation.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.An investigation was performed on similar devices and noted that the rust/corrosion and fibers found on the complaint parts contained iron and chlorine.The devices are single use instruments was manufactured in 2014.Process review revealed that the current process is different from that of during that time of manufacturing.There is a possibility that the part could have been cleaned improperly at that time.Based on this information, we have reason to suspect the device failed to meet specifications.All parts found on complaints were manufactured prior to 2017.It is believed that the cleaning process has been updated since the occurrence of this incident.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: TRAUMA IMPLANT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9689113
• MDR Text Key: 178532381
• Report Number: 1020279-2020-00505
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1