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

Model Number	71158022
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem 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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the screwdriver in the packaging was found to have rust present along its tip.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review concluded that the event reported under this complaint was previously identified and a health hazard evaluation was opened.The following actions were taken: a biocompatibility evaluation was performed and determined that the rust/corrosion reported in the complaints is deemed to present low biological risk with the transient tissue contact of the instrument.According to process procedure, the product should be passivated, in order to remove any residual machine tool free iron from the surface to prevent oxidation.A review made by the quality engineering team revealed that complaints were received detailing that the drivers in the kits exhibited rust/corrosion when opened as new.Tests on the rust/corrosion were performed by the quality team and 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 drad 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 detailing that iron and chlorine were found when the parts were analyzed.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be contamination to come in contact with the parts in the cleanroom.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: D-RAD SMART PACK 4H RIGHT WIDE PLATE
• Common Device Name: 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: 15213807
• Report Number: 1020279-2022-03655
• Device Sequence Number: 4717093
• Product Code: HRS
• UDI-Device Identifier: 00885556364598
• UDI-Public: 00885556364598
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K132296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71158022
• Device Catalogue Number: 71158022
• Device Lot Number: 17HT91800A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown