MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203013

Device Problem Break (1069)

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

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the inner blade broke during the procedure.No pieces were introduced into the patient.A backup device was available to complete the procedure with minimal delay.No patient impact was reported.

Manufacturer Narrative

One 72203013 incisor plus platinum 4.5 mm blade returned.This device is in damaged condition.There is a bow of the overall length of the outer blade.There are wear bands on the outer surface of the inner blade.The sluff chamber of the inner blade has attained pressure cracks.These conditions are symptoms of force and excessive side load applied.

• Brand Name: 4.5MM INCISOR PLUS PLATINUM BLADE
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6897226
• MDR Text Key: 87727478
• Report Number: 1219602-2017-01213
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR