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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200616
Device Problems Overheating of Device (1437); Protective Measures Problem (3015)
Patient Problem Burn(s) (1757)
Event Date 06/12/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: case-(b)(4).
 
Event Description
It was reported that during a shoulder arthroscopy surgery, after 1 hour of procedure, the mdu alarm started. The hand piece was reviewed and it was noticed a increasing of the temperature of the hand piece. Another arthroscopy set was used and the shaver was changed too. At the end of the surgery it was noticed that in the patient´s thigh skin there was a phlycten where the hand piece rested due the hand piece increasing of temperature. Surgical delay of less than or equal to 30 minutes. No further complications were reported.
 
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Brand NameMOTOR DRIVE UNIT HAND CNTRL PWRMX EL
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 Key12214125
MDR Text Key263096441
Report Number1643264-2021-02221
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200616
Device Catalogue Number72200616
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2021
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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