MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL (BX6); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205345
Medical Device Problem Codes	Flaked (1246); Material Integrity Problem (2978); Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three (3) incisor plus bl from the same package were no longer functional after a short time.After the blade was connected to the handpiece it did not work.It is unknown whether the event happened during surgery or if there was patient involvement; however, the procedure was completed with a surgical delay of less than 30 minutes, using a smith and nephew backup device.No further complications were reported.
Additional Manufacturer Narrative
H10: (b)(4).H3, h6: the reported devices were received for evaluation.A visual inspection revealed eight devices, three opened and five unopened/sealed, were returned in original packaging with the batch number of the complaint on the label.The five unopened devices had no visible defects in the device or packaging.The three used devices have heavy bio debris present.The teeth on all three blades show wear.Metal flakes are present on all three devices.Scoring is present on all three inner blades.A functional evaluation was performed on the returned devices and found the heavy dried bio debris made separating the inner blades from the outer blades difficult.Hard pieces of bio debris can be felt on all three, when manually turning the blades.Running an unopened blade from the same box/lot, on a reference system, showed it functioned as intended in all modes.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.The root cause has been associated with unintended use of the device.Factors, which may have contributed to the reported event include: (1) excessive force.(2) tissue thickness.No containment or corrective actions are recommended at this time.

• Brand Name: BOXED INCISOR PLUS BL (BX6)
• 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: 19121919
• Report Number: 1219602-2024-00796
• Device Sequence Number: 12824073
• Product Code: HAB
• UDI-Device Identifier: 03596010251688
• UDI-Public: 03596010251688
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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 Catalogue Number: 7205345
• Device Lot Number: 51143069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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