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

Catalog Number	7205305
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction surgery, the planer has rust spots and cannot be used.Additional information was received and was confirmed that the device was used in the patient.No patient injury or significant delay were reported.Back up device was available.
Additional Manufacturer Narrative
One 7205305 3.5mm full radius disposable blade used for treatment, was returned for evaluation.The complaint stated: ¿the planer has rust spots and cannot be used.Additional information was received and was confirmed that the device was used in the patient.No patient injury or significant delay were reported.Back up device was available.¿ the device is in good condition.Silicone is used in during manufacturing along with a silver plating process.The silver plate surface may become discolored.Visual inspection indicated evidence of silicone and silver tarnish discoloration.To produce a device with less friction, silicone is used for additional lubrication between inner and outer blades.This may encourage subsequent tarnish of the silver.It has been determined that the excess silicone located at the bottom of the blade tip, or the appearance of discoloration will not impact the patient or end user.¿surillium is the proprietary, silver coating that helps prevent shedding.It improves lubricity and allows for reduced frictional contact between the stainless steel inner and outer blades.It also discolors when exposed to certain elements.The red substance that's occasionally found on our blades and peaks curiosity of our customers is actually a silicone lubricant from the manufacturing process.Testing has confirmed that the silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.¿ the silicone and silver improves performance of the device and has been determined to have no adverse effect on patient safety.This observation is monitored through surveillance.Complaint history lot review found no other complaint for this lot.Product met specifications upon release to distribution.

• 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: 8746541
• Report Number: 1219602-2019-00756
• Device Sequence Number: 11336896
• Product Code: HAB
• UDI-Device Identifier: 03596010251336
• UDI-Public: 03596010251336
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 07/22/2019

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: 7205305
• Device Lot Number: 50758985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1