MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 5.5MM FULL RADIUS PLATINUM SERIES; SAW, POWERED, AND ACCESSORIES

Catalog Number	72203522
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a knee scope surgery, the shaver was shooting debris into the knee.All particles were removed from patient.A backup device was available to complete the procedure successfully.Delay or patient injuries were not reported.
Additional Manufacturer Narrative
One used 5.5mm full radius platinum series blade was returned for evaluation.Visual assessment of the blade confirmed the reported complaint.Plating appears to have flaked off of the tip of the inner blade.The edgeform teeth also show some slight abrasion.There is significant cracking were the outer blade interfaces with the adapter body.Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.The condition of the blade indicates it was subjected to excessive side-loading during use.¿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¿.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The manufacturer has become aware that the mdr is a duplicate of the mdr 1219602-2019-00438.An amend on this regard has been submitted to health canada as well.

• Brand Name: 5.5MM FULL RADIUS PLATINUM SERIES
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8714904
• Report Number: 1219602-2019-00730
• Device Sequence Number: 1685584
• Product Code: HAB
• UDI-Device Identifier: 00885554027853
• UDI-Public: 00885554027853
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2019

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: 11/12/2023
• Device Catalogue Number: 72203522
• Device Lot Number: 50770101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 08/27/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/23/2019; 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1