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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL, SAGITTAL SAW POWER SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVCE REPL, SAGITTAL SAW POWER SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205786S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2014
Event Type  malfunction  
Event Description
It was reported that the device is not reciprocating.
 
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Brand NameSVCE REPL, SAGITTAL SAW POWER
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
james gonzales
7000 w. william cannon drive
austin, TX 78735
MDR Report Key6994892
MDR Text Key91299706
Report Number1643264-2017-01354
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
Type of Report Initial
Report Date 11/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205786S
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2014
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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