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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. BLADE,3.5 BONE CUTTER FULL RADIUS,DISP SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7210486
Device Problems Material Discolored (1170); Knife (3156)
Patient Problem No Code Available (3191)
Event Date 04/19/2018
Event Type  Injury  
Event Description

It was reported that during the procedure the blade was discolorating. They continued using the device to resect the meniscus and the meniscus stained by this blade discoloration. The customer concerns about the impact to the patient since the residue may remain in the patient body. No patient injury was reported.

 
Manufacturer Narrative

One 3. 5 bone cutter blade was returned for evaluation. Visual assessment of the blade showed residual silicone on the inner blade. The red substance that's occasionally found on our blades 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. During the manufacturing process, we coat our inner shaver blades in a silicone bath to provide additional lubrication between the blades when used during the surgical procedure. Occasionally, when applying the silicone lubricant, some of it may pool within the shaver blade and, after some time, forms an area of red substance. No clinical/medical documents were provided with this complaint and no patient reaction was reported.

 
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Brand NameBLADE,3.5 BONE CUTTER FULL RADIUS,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 Key7528837
MDR Text Key108733356
Report Number1219602-2018-00621
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device Catalogue Number7210486
Device LOT Number50694148
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/31/2017
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: 05/21/2018 Patient Sequence Number: 1
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