MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,3.5MM ELITE FULL RADIUS; SAW, POWERED, AND ACCESSORIES

Model Number	7210751
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that some small metal fragments were nudged off the top inner part of the shaver blade.It is unknown if all the pieces were removed from the patient, however, this does not represent any serious injury to the patient.
Additional Manufacturer Narrative
One 3.5 mm full radius blade was received for evaluation.Functional inspection confirmed the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.Visual assessment showed a surface abrasion on the inner distal tip.One of the edgeform teeth of the inner blade showed slight damage.The outer blades edge form has corresponding damage.All indications point to the inner blade edge form/teeth contacting the outer blade edge form use.

• Brand Name: BLADE,3.5MM ELITE FULL RADIUS
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7632574
• Report Number: 1219602-2018-00793
• Device Sequence Number: 13927860
• Product Code: HAB
• UDI-Device Identifier: 03596010532596
• UDI-Public: (01)03596010532596(17)210601(10)50603951
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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: 06/01/2021
• Device Model Number: 7210751
• Device Catalogue Number: 7210751
• Device Lot Number: 50603951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/23/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1