MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL 4.5MM, DSPL., EP-1; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205306

Device Problem Metal Shedding Debris (1804)

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

Event Date 02/23/2018

Event Type  malfunction  

Event Description

It was reported that during an ankle scope, device left metal shaving in the joint.Metal was debrided out during open part of procedure.Another hand piece and blade were used to complete the surgery with no major delay or patient injury.

Manufacturer Narrative

Definitive conclusions, accurate investigation and evaluation are not possible since product was not returned by customer for evaluation.No further actions pursued at this time.A manufacturing dhr review was performed by querying the complaint database history for this product code which revealed other complaints of this nature.

• Brand Name: FULL RADIUS BL 4.5MM, DSPL., EP-1
• 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 w. william cannon drive; austin, TX 78735
• MDR Report Key: 7364034
• MDR Text Key: 103436157
• Report Number: 1219602-2018-00354
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• 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