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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problems Device Stops Intermittently (1599); Temperature Problem (3022); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2017
Event Type  malfunction  
Event Description
It was reported the powermax elite mdu hand control was heating up, clicking, and intermittently working. A back up device was utilized to complete the procedure. No patient injury or complications were reported.
 
Manufacturer Narrative
The reported complaint of heating up, clicking, and intermittently working could not be confirmed. Product did not overheat, click, or work intermittently during functional testing. At no time did mdu overheat, click, or work intermittently. All functions perform as expected. No problem found.
 
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Brand NameSVC REPL,MDU, HAND CNTRL, PWRMX
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
jim gonzales
7000 w. william cannon drive
austin, TX 77035
5123585706
MDR Report Key6417375
MDR Text Key70541079
Report Number1643264-2017-00151
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,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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