MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR BLADE,5.5MM,EP-1, DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205311

Device Problem Naturally Worn (2988)

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

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported there was metal wear from the shaver.A backup device was readily available.There were no delays or patient injuries reported.

Manufacturer Narrative

The blade was evaluated for rotation and was found to rotate freely; no friction was felt in the unloaded condition.Visual assessment of the inner blade edgeform showed the damage, the inner edgeform teeth have been degraded.There is also a corresponding contact points on the id of the outer blade surface.In addition there is metal debridement appoximately ½ inch from the slough channel.The tooth wear indicates excessive side loading took place causing the reported shedding.Per the devices ifu ¿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¿.No root cause related to the manufacture of the device can be established.Further investigation is not warranted at this time.

• Brand Name: SYNOVATOR BLADE,5.5MM,EP-1, DSPL 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6699010
• MDR Text Key: 79670355
• Report Number: 1219602-2017-00734
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 7205311
• Device Lot Number: 50861160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2015
• 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