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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET SCREW DRIVER; SCREWDRIVER
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SMITH & NEPHEW, INC. SET SCREW DRIVER; SCREWDRIVER Back to Search Results
Catalog Number 71665014
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2019
Event Type  malfunction  
Event Description
It was reported that during surgery, the device was damaged due to normal wear and tear.No backup device.No delay.No revision surgery.
 
Manufacturer Narrative
The associated complaint devices were not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.Credit cannot be issued for the devices.
 
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Brand Name
SET SCREW DRIVER
Type of Device
SCREWDRIVER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8894982
MDR Text Key154330707
Report Number1020279-2019-03057
Device Sequence Number1
Product Code HXX
UDI-Device Identifier03596010518989
UDI-Public03596010518989
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71665014
Device Lot Number15MCT0015
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/19/2019
Initial Date FDA Received08/14/2019
Supplement Dates Manufacturer Received11/13/2019
Supplement Dates FDA Received11/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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