MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR 5.5MM EP-1 DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205314
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy metal filings were seen when using the incisor 5.5mm ep-1 dspl blade.No undue force was applied on the shaver blade.A second blade was opened and used to remove metal debris.The procedure was completed with a non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation of the device showed the color scheme matches the drawing, the teeth on both the inner and outer blades appear sharp.There is bio debris on the outside blade shaft.Separation of the inner and outer blades showed additional bio debris on the inner blade shaft and teeth.There are multiple areas of scarring on the inner shaft, most notably, just under the proximal edge of the window and at the proximal end of the shaft.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 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 complaint was confirmed and the root cause was associated with unintended use of the device.Factor that may have contributed to the reported event is insufficient irrigation during use.No containment or corrective actions are recommended at this time.

• Brand Name: INCISOR 5.5MM EP-1 DSPL 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: 16855828
• Report Number: 1219602-2023-00627
• Device Sequence Number: 20525791
• Product Code: HAB
• UDI-Device Identifier: 03596010251428
• UDI-Public: 03596010251428
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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,Followup
• Report Date (Section B): 08/31/2023

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
• Device Model Number: 7205314
• Device Catalogue Number: 7205314
• Device Lot Number: UNKNOWN
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown