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

Catalog Number	7205310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code (b)(6).
Event or Problem Description
It was reported that the surgeon applied to much pressure on the product and the synovator blade cracked during the procedure.A backup device was available to complete the procedure with no delay or patient injuries reported.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.Additional information was received from customer to confirm that device did not break inside the patient therefore the event is not considerable reportable.

• Brand Name: SYNOVATOR BLADE,BOXED4.5 EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8051625
• Report Number: 1219602-2018-01512
• Device Sequence Number: 1833531
• Product Code: HAB
• UDI-Device Identifier: 03596010251381
• UDI-Public: 03596010251381
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2022
• Device Catalogue Number: 7205310
• Device Lot Number: 50689409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1