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

Model Number 7210976

Device Problem Material Disintegration (1177)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7807067
• MDR Text Key: 118093685
• Report Number: 1219602-2018-01098
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010532626
• UDI-Public: (01)03596010532626(17)230117(10)50708552
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 87