MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR BLADE,BOXED4.5 EP-1; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205310

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

Awaiting receipt of device.

Event Description

It was reported tip of the inner blade from a shaver blade was reported missing.

Manufacturer Narrative

Examination was not possible, as the device will not be returned.The investigation was limited to the information provided.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: SYNOVATOR BLADE,BOXED4.5 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; austin, TX 78735 ; 5123585706
• MDR Report Key: 6221357
• MDR Text Key: 64055269
• Report Number: 1219602-2017-00017
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205310
• Device Lot Number: 50724036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 98