MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	72203013
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an acl reconstruction procedure, the incisor plus platinum blade caused black shedding in the knee joint.Suction was attempted to retrieve the pieces, but the material had a "graphite" type smear on the tissue.The procedure was completed using the same device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H6: ten unopened/sealed devices with original packaging from the same lot number were received for evaluation.The color scheme of the devices matches the print.There are no visible defects with the ten packaging seals.Three devices were opened for evaluation.The silicone lubricant, on all three devices, has solidified onto the tip of the inner blades and inside the tip of the outer blade.The wood end of an applicator will move the lubricant which is the consistency of warm wax.A functional evaluation of the three devices found that when connected to a reference mdu, they spin as intended.No shedding was observed.The solidified lubricant was still present on the tips of the inner blades.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the manufacturing procedure, found that the operator should visually inspect the inner and outer blade assembly for any foreign material or discoloration at eye level.Inspect all internal and external features of the assembly.A clinical review states that although the clinical root cause of the event cannot be concluded with certainty, it is potentially due to a combination of shredded material (possibly secondary to excessive side loading during use/user technique) and silicone from the benign lubrication process.The silicone lubricant does not pose any risk to patient safety.The instrument is manufactured and intended as an externally communicating device with short-term bone/tissue contact (<24 hours) and long-term implantation data is not available.The root cause was not determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the failure include temperature changes that exposed the lubricant to low temperatures, causing it to thicken or solidify; aging of the lubricant, especially if it wasn't stored properly, resulting in changes in texture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: 4.5MM INCISOR PLUS PLATINUM BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19800018
• Report Number: 1219602-2024-01574
• Device Sequence Number: 20713960
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72203013
• Device Lot Number: 51209655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/07/2024
• Date Device Manufactured: 03/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown