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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL MDU CNTRL PWRMX ELITE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVCE REPL MDU CNTRL PWRMX ELITE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616SR
Device Problem Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during a shoulder scope the motor drive unit starts and stops on its own. The procedure was completed with a backup device and no delay or further complications 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 NameSVCE REPL MDU CNTRL PWRMX ELITE
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11125808
MDR Text Key225493576
Report Number1643264-2021-00046
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
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 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616SR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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