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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
Model Number 7210486
Device Problem Material Discolored (1170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2018
Event Type  Injury  
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-(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.
 
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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
5123585706
MDR Report Key7806173
MDR Text Key118094973
Report Number1219602-2018-01109
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 Expiration Date10/08/2019
Device Model Number7210486
Device Catalogue Number7210486
Device Lot Number50657623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2018
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 Manufactured04/08/2017
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: 08/22/2018 Patient Sequence Number: 1
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