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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 Corroded (1131)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that some blades appeared rusty and metal shards were coming off the tip during procedure. No patient injury reported.
 
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.
 
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.
 
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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
MDR Report Key7524119
MDR Text Key108641493
Report Number1219602-2018-00607
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2022
Device Model Number7205305
Device Catalogue Number7205305
Device Lot Number50651523
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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