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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER,5.5,EP-1,DSPL BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. ABRADER,5.5,EP-1,DSPL BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205325
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during the procedure, while the blade was being used in the patient, plastic shavings of the connector fell off into the joint. The plastic shavings were tried to be removed by forceps, but could not completely be taken out from the patient. It is unknown if there was a surgical delay. The procedure was completed with the same device and no patient injuries were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameABRADER,5.5,EP-1,DSPL 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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9390505
MDR Text Key168468538
Report Number1219602-2019-01505
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205325
Device Catalogue Number7205325
Device Lot Number50779783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2019
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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