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

Model Number 7205305

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event 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.

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-0205015.Two are intended to be applied to related complaints c-0205266 and c-0205271.All the complaints stated: "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." the event descriptions included the following information reported: "rep has the old blades, but not the one used with a patient.It was reported as having been within its correct expiry date parameters." 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." and "testing has confirmed that the red silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing." the silicone and silver improve performance of the device and have been determined to have no adverse effect on patient safety.

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: FULL RADIUS BLADE,3.5MM,DISP
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7806176
• MDR Text Key: 118095315
• Report Number: 1219602-2018-01110
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251336
• UDI-Public: (01)03596010251336(17)220804(10)50678353
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: 7205305
• Device Catalogue Number: 7205305
• Device Lot Number: 50678353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other