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	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy procedure, a part of the tip of the inner bonecutter blade was peeled off.The procedure was successfully completed using a back-up device.It is unknown if there was a delay.It is unknown if the peel part was removed from the patient.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A review of the customer provided image reveals the distal tip of the blade shows the outer coating of the device peeling.A visual inspection revealed the inner blade exterior coating has began peeling off.The device appears worn from use.No other deformation revealed.A functional evaluation revealed the device function as intended clockwise, counterclockwise, and while oscillating without excessive noise or grinding.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of excessive force or contact with another source.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.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 concluded this was an isolated event.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A review of the customer provided image reveals the distal tip of the blade shows the outer coating of the device peeling.A visual inspection revealed the inner blade exterior coating has began peeling off.The device appears worn from use.No other deformation revealed.A functional evaluation revealed the device function as intended clockwise, counterclockwise, and while oscillating without excessive noise or grinding.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with component failure.Factors, which could have contributed to the complaint event, include an application of excessive force or contact with another source.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: 12297770
• Report Number: 1219602-2021-01684
• Device Sequence Number: 11908581
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2022

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 Expiration Date: 07/08/2023
• Device Model Number: 7206011
• Device Catalogue Number: 7206011
• Device Lot Number: 50915094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 02/23/2022
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/14/2021; 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• 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: Other
• Patient Sex: Unknown