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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BARREL ABRADER,POWER-MINI, DISP,2.9 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BARREL ABRADER,POWER-MINI, DISP,2.9 SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number ED72201520
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2018
Event Type  malfunction  
Event Description
It was reported that there were pieces of metal flying off of them while it was being used in a case. No patient injury was reported. All the pieces were removed from the patient.
 
Manufacturer Narrative
One single (b)(4) disposable 2. 9mm mini magnetic barrel abrader blade returned. These are sold as a box of six. This product is not intended to be or tested to be sold individually. The complaint stated: "it was reported that there were pieces of metal flying off of them while it was being used in a case. No patient injury was reported. All the pieces were removed from the patient. " the shafts of the inner as well as the outer blades are bowed. They spin, but with resistance and drag. This condition is a symptom of excessive side loading. This is a small scale device which is not intended to have pressure applied. Per ifu: "excessive "side-loading" on the blade during use does not improve cutting performance, and in extreme cases may result in wear and degradation of the inner blade". It was also noted that the inner blade friction sleeves are out of location. There are light ding marks on the blade edges. No other abnormalities were reported for this manufacturing lot. No root cause related to the manufacture of the device was established.
 
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Brand NameBARREL ABRADER,POWER-MINI, DISP,2.9
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 Key7783094
MDR Text Key117270859
Report Number1219602-2018-01067
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2019
Device Model NumberED72201520
Device Catalogue NumberED72201520
Device Lot Number50631214
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2016
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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