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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE
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SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE Back to Search Results
Catalog Number 72200873
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
Event Type  malfunction  
Event Description
It was reported that during an acl reconstruction surgery, the host did not work.The procedure was completed with a competitor device.It is unknown if a delay was caused due to the device malfunction.No patient injuries were reported.
 
Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A visual inspection of the customer provided image showed the dii controller display is missing the icon indicating communication with the motor drive unit.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.The complaint was confirmed and the root cause has been associated with an electrical component failure.
 
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Brand Name
DII CONTROLLER
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key8873666
MDR Text Key153697572
Report Number1643264-2019-00524
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010607409
UDI-Public03596010607409
Combination Product (y/n)N
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72200873
Was Device Available for Evaluation? No
Date Manufacturer Received09/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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