MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR,4.5 CONCAVE (BX/6); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205334
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was labeled as a concave blade but it was a convex blade.There were no significant delay or patient injuries reported.Back up device was used in order to complete the procedure.The wrong device was used in the patient.
Additional Manufacturer Narrative
One 7205324 concave 4.5mm synovator blade reported on.This product is sold as a box of 6.The products are not intended to be sold individually.The complaint was categorized as a labeling situation.The labeling information is consistent with manufacturing and our electronic database information as a concave configured product.This information would then categorize this allegation as an incorrect product.There were no allegations for the other five from this shelf carton.There were no other allegations at all for this manufacturing lot.There is no data to support an incorrect blade was packaged.There were two photos provided although they did not display the entire device for confirmation.Only the tip was shown.In addition, reaching out for additional photos relayed that the product was discarded.Correction : user facility should not be marked.

• Brand Name: SYNOVATOR,4.5 CONCAVE (BX/6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8479317
• Report Number: 1219602-2019-00383
• Device Sequence Number: 1253286
• Product Code: HAB
• UDI-Device Identifier: 03596010251619
• UDI-Public: 03596010251619
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 09/15/2023
• Device Catalogue Number: 7205334
• Device Lot Number: 50759056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1