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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER, 3.5, MAG-MINI, DISP. BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. ABRADER, 3.5, MAG-MINI, DISP. BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72201519
Device Problems Detachment of Device or Device Component (2907); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2019
Event Type  Malfunction  
Event Description

It was reported that during the procedure for resection of bone spurs, the tip of the blade were came out. The piece was removed. No patient injuries and complications were reported.

 
Manufacturer Narrative

One (b)(4) mini mag 3. 5mm blade returned. The complaint stated: ¿the tip of the blade came out. ¿ the entire product was returned for evaluation. No original packaging was present except a product label. There is evidence of a previous weld where there is discoloration generated from the process. There is a fractured bead at the tube edge, therefore the blade bulb is now able to be separated from the mating blade tube. On the inner blade, the proximal protective sleeve has migrated forward out of position specified by the drawing. (the spec is for the sleeve¿s front edge to be 2. 490¿ from the blade bulb end. The edge is @ 1. 40¿. ) rotational scratches; skiving, was found on the surface of the inner blade. There is grit from skiving adhered to the blade edges. Symptoms indicate that force was a factor for the damages attained. As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument. No root cause related to the manufacture of this device was confirmed. Correction.

 
Event Description

It was reported that during the procedure for resection of bone spurs, the tip of the blade came out. The piece was removed from patient. There was no backup device to complete the procedure. No patient injuries were reported.

 
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Brand NameABRADER, 3.5, MAG-MINI, DISP. BLADE
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 w william cannon drive
austin, TX 78735
5123585706
MDR Report Key8267323
MDR Text Key133832275
Report Number1219602-2019-00100
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72201519
Device LOT Number50752582
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/11/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/12/2018
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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