MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR BLADE 3.5MM DSPL EP-1; SAW, POWERED, AND ACCESSORIES

Model Number	7205312
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a knee surgery, the tip of the "3.5mm incisor blade" came off inside the patient.In consequence, the piece was removed from the patient.The procedure was successfully completed without delay using the same device.No 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
The reported 3.5mm incisor blade, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, a piece of the blade broke off during use and was removed from the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive side loading during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: INCISOR BLADE 3.5MM DSPL EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10251818
• Report Number: 1219602-2020-01000
• Device Sequence Number: 14166315
• Product Code: HAB
• UDI-Device Identifier: 03596010251404
• UDI-Public: 03596010251404
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 11/19/2024
• Device Model Number: 7205312
• Device Catalogue Number: 7205312
• Device Lot Number: 50840658
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention