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

Model Number 71158022

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the driver inside the kit has signs of rust.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.This event was evaluated through our internal nonconformance process for corrective action.A health hazard evaluation was also performed.The evaluation determined that, based on the biocompatibility evaluation, the rust/corrosion reported in the complaint is deemed to present low biological risk with the transient tissue contact of this instrument.Therefore, the worst case would be a local adverse tissue reaction not likely to be perceptible to the patient above and beyond the normal local reactions due to the surgery and implantation.The potential probable cause for this event is likely a manufacturing process issue.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: D-RAD SMART PACK 4H RIGHT WIDE PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12046634
• MDR Text Key: 257743836
• Report Number: 1020279-2021-05365
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556364598
• UDI-Public: 00885556364598
• Combination Product (y/n): N
• PMA/PMN Number: K132296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71158022
• Device Catalogue Number: 71158022
• Device Lot Number: 14GM19171R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1