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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN STYLUS 1MM; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

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SMITH & NEPHEW, INC. LGN STYLUS 1MM; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY Back to Search Results
Catalog Number 71434333
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the screw came out during procedure.The part was removed from the patient.A smith & nephew back up was available.There was a 1-2 minute delay in procedure, but there was no harm to the patient.
 
Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The arm bolt came out of the device, causing it to disassemble and become inoperable.The bolt and washer were not returned.The device was manufactured in 2014 and exhibits signs of extensive wear usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
 
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Brand Name
LGN STYLUS 1MM
Type of Device
PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9258150
MDR Text Key164411440
Report Number1020279-2019-03842
Device Sequence Number1
Product Code MBH
UDI-Device Identifier03596010549839
UDI-Public03596010549839
Combination Product (y/n)N
PMA/PMN Number
K121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/12/2019
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 Number71434333
Device Lot Number14FM05262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
Initial Date Manufacturer Received 10/10/2019
Initial Date FDA Received10/30/2019
Supplement Dates Manufacturer Received11/06/2019
Supplement Dates FDA Received11/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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