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	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the device was shedding metal debris during an ankle arthroscopy.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.

• 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: 8029004
• Report Number: 1219602-2018-01485
• Device Sequence Number: 1421312
• Product Code: HAB
• UDI-Device Identifier: 03596010251381
• UDI-Public: 03596010251381
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 01/22/2023
• Device Catalogue Number: 7205310
• Device Lot Number: 50709446
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1