MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW; SAW, POWERED, AND ACCESSORIES

Model Number	7210976
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 90 seconds after starting meniscal resection, metal debris occurred in the joint.A backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
The reported incisor plus elite blade, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the blade shed during use, causing metal debris to enter the joint space.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive "side-loading" on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7807067
• Report Number: 1219602-2018-01098
• Device Sequence Number: 1940167
• Product Code: HAB
• UDI-Device Identifier: 03596010532626
• UDI-Public: (01)03596010532626(17)230117(10)50708552
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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 Expiration Date: 01/17/2023
• Device Model Number: 7210976
• Device Catalogue Number: 7210976
• Device Lot Number: 50708552
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 87