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

Model Number	7205305
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that some blades appeared rusty and metal shards were coming off the tip during procedure.No patient injury reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.
Additional Manufacturer Narrative
7205305 3.5mm full radius disposable blades returned.Two devices arrived packaged together.It was confirmed that there were two initial complaints opened for the first blade and subsequently two more for the additional blade received for a total of four related complaints.They are not serialized and therefore it is not fully determined which complaint applies to which device.They both stated: "as reported: rep was made aware (by nurse) that some blades appeared rusty and metal shards were coming off the tip, into the patient." it was later confirmed that there were two complaints opened for each device; total four related complaints.This product is not serialized and therefore it is not fully determined which complaint applies to which device.Visual inspection indicates presence of an internally tested silicone used in the manufacturing process of the silver plating process.The metal surface has become discolored.The silicone is used for additional lubrication between inner and outer blades to produce a device with less friction.This may encourage subsequent tarnish which can shed.There were also wear bands skived on the surface material of the inner blade.This is a symptom of inadvertent side loading.Internal testing indicates that these visual observations are cosmetic.The silicone and silver improve performance of the device and do not have an adverse effect on patient safety.

• Brand Name: FULL RADIUS BLADE,3.5MM,DISP
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7524119
• Report Number: 1219602-2018-00607
• Device Sequence Number: 1439194
• Product Code: HAB
• UDI-Device Identifier: 03596010251336
• UDI-Public: (01)03596010251336(17)220307(10)50651523
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2018

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: 03/07/2022
• Device Model Number: 7205305
• Device Catalogue Number: 7205305
• Device Lot Number: 50651523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/05/2018; 08/27/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 07/06/2018; 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1