MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED F/R BL 4.5MM SERIES 3000 /6; SAW, POWERED, AND ACCESSORIES

Model Number	7206011
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, during set up for surgery, when the package was opened, the surgeon found that the tip of the "4.5mm full radius disposable blades" was dirty.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed the device no longer had original packaging.There was visible evidence of silver tarnish.Silicone is used in during manufacturing along with the silver-plating process.The silver plate surface may become discolored.Visual inspection indicated evidence of silicone and silver tarnish discoloration.To produce a device with less friction, silicone is used for additional lubrication between inner and outer blades.This may encourage subsequent tarnish of the silver.It has been determined that the excess silicone located at the bottom of the blade tip, or the appearance of discoloration will not impact the patient or end user.¿surillium is the proprietary, silver coating that helps prevent shedding.It improves lubricity and allows for reduced frictional contact between the stainless-steel inner and outer blades.It also discolors when exposed to certain elements.The orange-red substance that's occasionally found on our blades and peaks curiosity of our customers is actually a silicone lubricant from the manufacturing process.¿testing has confirmed that the silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.¿ the silicone and silver improves performance of the device and has been determined to have no adverse effect on patient safety.A functional evaluation of the returned device is not applicable as a visual failure was reported.A complaint history review concluded this was a repeat issue.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate a review of the inspection process found that each component should be visually inspected for all non-conforming attributes defined in the procedure.It was determined the device contributed to the reported event.The complaint was confirmed, and the root cause was associated with component failure.Factors that could contribute to the reported event include exposure to elements over time which can lead to the discoloration.The blades are still biocompatible and non-toxic, despite the discoloration.No containment or corrective actions are recommended at this time.

• Brand Name: BOXED F/R BL 4.5MM SERIES 3000 /6
• 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: 11349113
• Report Number: 1219602-2021-00361
• Device Sequence Number: 17161110
• Product Code: HAB
• UDI-Device Identifier: 03596010440242
• UDI-Public: 03596010440242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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 Expiration Date: 03/14/2022
• Device Model Number: 7206011
• Device Catalogue Number: 7206011
• Device Lot Number: 50828112
• 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: 01/29/2021
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2019
• 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