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

Model Number	7210486
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the inside blade had changed color versus the outside sheath, as soon as it was visible on screen as the debider was inserted into the joint.Another blade of same type was used, but all available had similar discoloration.Patient injuries were reported.
Additional Manufacturer Narrative
Three 7210486 disposable 3.5mm full radius bone cutter blades returned.This product is sold as a box set of six blades.These are not to be sold individually.Three unused devices were returned together identified as c-(b)(6).Two are intended to be applied to related complaints c-(b)(6) and c-(b)(6).The devices returned are new and unopened.Therefore the device observed during the surgery is unavailable, but the surgeon felt that these devices subsequently collected, were representative of the same condition found during the procedure.Visual inspection indicates presence of silicone used in during manufacturing in the silver plating process.The metal surface may become discolored.To produce a device with less friction, silicone is used for additional lubrication between inner and outer blades.This may encourage subsequent tarnish which may shed.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.The silicone and silver improve performance of the device and have been determined to have no adverse effect on patient safety.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ·patient information ·surgical procedure/post-operative care review ·device labeling (including technique guides, ifus, etc.) insufficient clinically relevant documentation was provided; therefore a thorough medical investigation could not be performed.However, blade discoloration has previously been addressed and documented on capa (b)(4) 2017): "the investigations following the return of the products determined that the appearance of tarnish and discoloration do not have an adverse effect on the patient, or performance of the device per the safety affairs memo: disposable blade residual material investigation.Visual assessments following the complaints for discoloration on 3.5 full radius blades from p01-pl2 of 2016 also 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." additionally, per the "saleslife online" memo, testing has confirmed that the red silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.It remains unknown if there was any surgical delay or further patient impact due to the reported issue.Should additional information become available, the medical assessment may be re-evaluated.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Insufficient clinically relevant documentation was provided; therefore a thorough medical investigation could not be performed.However, blade discoloration has previously been addressed and documented on capa ((b)(4) 2017): "the investigations following the return of the products determined that the appearance of tarnish and discoloration do not have an adverse effect on the patient, or performance of the device per the safety affairs memo: disposable blade residual material investigation.Visual assessments following the complaints for discoloration on 3.5 full radius blades from p01-pl2 of 2016 also 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." additionally, per the "saleslife online" memo, testing has confirmed that the red silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.It remains unknown if there was any surgical delay or further patient impact due to the reported issue.Should additional information become available, the medical assessment may be re-evaluated.
Additional Manufacturer Narrative
It was mentioned that there was an injury and mentioned a surgery as the description of such injury.However no clear response was received when we requested several times what was the nature of the surgery or injury allegedly reported as this description fails to establish the relation with the alleged reason for report (discoloration).It was also established that no medical or surgical intervention was required as a result of the incident and that ¿unknown theatre time delay, unknown patient, unknown if any damage was done to patient.¿.This is ambiguous information that made us conclude that based on the available information, it is unknown if there was a harm done to patient as a result of this event.Additionally we don¿t have evidence to believe this malfunction results in the failure of the device to perform its essential function or compromises the device¿s therapeutic effectiveness in a way that could cause or contribute to a death or serious injury.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: BLADE,3.5 BONE CUTTER FULL RADIUS,DISP
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7806173
• Report Number: 1219602-2018-01109
• Device Sequence Number: 1400022
• Product Code: HAB
• UDI-Device Identifier: 03596010494733
• UDI-Public: (01)03596010494733(17)191008(10)50657623
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2019
• Device Model Number: 7210486
• Device Catalogue Number: 7210486
• Device Lot Number: 50657623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 07/29/2018
• Supplement Date Received by Manufacturer: 07/29/2018; 09/27/2018; 05/13/2019
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 08/23/2018; 09/28/2018; 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other