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

Catalog Number 7210976

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/04/2018

Event Type  malfunction  

Event Description

It was reported that plenty of metal pieces get loose from the blade.A backup device was available to complete the procedure with no significant delay or patient injuries.

Manufacturer Narrative

Age at time of event added.Patient sex added.Information added.Unique identifier (udi), lot number and expiration date added.Device manufacture date added.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• 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: 7889959
• MDR Text Key: 120848879
• Report Number: 1219602-2018-01276
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2022
• Device Catalogue Number: 7210976
• Device Lot Number: 50682352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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: 40 YR