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

Model Number 71158020

Device Problem Corroded (1131)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

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.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The screwdriver in the packaging was found to have rust present along its tip, rendering the device inoperative.According to a process procedure related to this device, the product should be passivated, in order to remove any residual machine tool free iron from the surface to prevent oxidation.According to a subject matter expert, it was determined that the rust/corrosion and fibers found on the complaint parts contains iron and chlorine.Determination of how and where the corrosion is occurring has not been reached.Root-cause determination has not been made.If an assumption was to be made it would be that due to the plastic parts contained in the kits being alcohol-wiped clean in the cleanroom prior to kitting, the possibility exists that an operator(s) during the said timeframe may have allowed some sort of contamination to come in contact with the parts.The makeup of this contamination would contain the elements of the said report from detailing that iron and chlorine were found when the parts were analyzed.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that the rust/corrosion reported in the complaints is deemed to present low biological risk with the transient tissue contact of this instrument and additional actions are being taken.Some potential probable causes for this event could include contamination during kitting.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 is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The screwdriver in the packaging was found to have rust present along its tip, rendering the device inoperative.According to a process procedure related to this device, the product should be passivated, in order to remove any residual machine tool free iron from the surface to prevent oxidation.According to a subject matter expert, it was determined that the rust/corrosion and fibers found on the complaint parts contains iron and chlorine.Determination of how and where the corrosion is occurring has not been reached.Root-cause determination has not been made.If an assumption was to be made it would be that due to the plastic parts contained in the kits being alcohol-wiped clean in the cleanroom prior to kitting, the possibility exists that an operator(s) during the said timeframe may have allowed some sort of contamination to come in contact with the parts.The makeup of this contamination would contain the elements of the said report from detailing that iron and chlorine were found when the parts were analyzed.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that the rust/corrosion reported in the complaints is deemed to present low biological risk with the transient tissue contact of this instrument and additional actions are being taken.Some potential probable causes for this event could include contamination during kitting.This issue was identified and is being addressed though our internal quality process.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 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 rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15213739
• MDR Text Key: 302123293
• Report Number: 1020279-2022-03652
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556364499
• UDI-Public: 00885556364499
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K132296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71158020
• Device Catalogue Number: 71158020
• Device Lot Number: 14KM10378R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1