MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IT WAS REPORTED THAT THE DEVICE WAS SHEDDING. THERE WERE NO DELAYS OR PATIENT IN SAW, POWERED, AND ACCESSORIES

Catalog Number 72200729

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/29/2018

Event Type  Malfunction  

Manufacturer Narrative

Examination is not possible, as the device will not be returned. The investigation could not draw any conclusions about the reported event without the return of the device. Further investigation is not warranted at this time.

Event Description

It was reported that the device was shedding. There were no delays or patient injuries reported.

Manufacturer Narrative

Examination is not possible, as the device will not be returned. The investigation could not draw any conclusions about the reported event without the return of the device. Further investigation is not warranted at this time.

• Brand Name: IT WAS REPORTED THAT THE DEVICE WAS SHEDDING. THERE WERE NO DELAYS OR PATIENT IN
• 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: 7725225
• MDR Text Key: 115186605
• Report Number: 1219602-2018-00952
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,USER F

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/26/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 72200729
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial