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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SHAVER CONTROLLER AND MOTOR DRIVE UNIT (MDU) DEV ARTHROSCOPE

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SMITH & NEPHEW, INC. UNKN SHAVER CONTROLLER AND MOTOR DRIVE UNIT (MDU) DEV ARTHROSCOPE Back to Search Results
Catalog Number UNKNOWN
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during a shoulder arthroscopic surgery, the power handle cable of the dll controller was heated and sometimes did not work. The procedure was completed without delay using a back-up device. No patient injury or other complications were reported.
 
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Brand NameUNKN SHAVER CONTROLLER AND MOTOR DRIVE UNIT (MDU) DEV
Type of DeviceARTHROSCOPE
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 Key12476413
MDR Text Key271554120
Report Number1643264-2021-02307
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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