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

Model Number 7205312

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 06/12/2020

Event Type  Injury  

Event 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.

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
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10251818
• MDR Text Key: 198148114
• Report Number: 1219602-2020-01000
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251404
• UDI-Public: 03596010251404
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205312
• Device Catalogue Number: 7205312
• Device Lot Number: 50840658
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention