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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP SAW, POWERED, AND ACCESSORIES Back to Search Results
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.
 
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Brand NameFULL RADIUS BLADE,3.5MM,DISP
Type of DeviceSAW, 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 Key7806176
MDR Text Key118095315
Report Number1219602-2018-01110
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
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 Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205305
Device Catalogue Number7205305
Device Lot Number50678353
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/22/2018 Patient Sequence Number: 1
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