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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Model Number 72202901
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2017
Event Type  malfunction  
Event Description
It was reported that anchor fell out.No significant delay or patient injury reported.
 
Manufacturer Narrative
One 4.5 footprint ultra pk suture anchor assembly was returned for evaluation.Inserter and anchor were returned, no stay suture.The anchor is soiled with human matter.Visual assessment of the anchor showed the anchor remains attached to the inserter.Inserter was functionally tested and the inner plug moved within the anchor as intended.The anchor is easily removed from the inserter.This investigation could not identify any evidence of product contribution to the reported complaint.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
 
Manufacturer Narrative
One fast-fix 360 curved needle delivery system was returned for evaluation.Visual assessment of the device showed the actuator is in its post t2 deployment position indicating a complete deployment.No ts or sutures remain on the insertion needle, however a 12 inch length of suture was returned.Examination of the suture found no abnormalities; its length is consistent with a successfully used device.The device was functionally tested for proper actuator advancement and cycling and was found to function as intended.It appears that the trigger was inadvertently advanced causing the pre-deployment of t2.Per the device ifu under warnings ¿do not push the deployment slider twice or the second implant will deploy prematurely¿.No root cause related to the manufacture of the device can be established.
 
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Brand Name
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7040352
MDR Text Key92973875
Report Number1219602-2017-01433
Device Sequence Number1
Product Code MBI
UDI-Device Identifier03596010650528
UDI-Public(01)03596010650528(17)210725(10)50612828
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K093897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/05/2018
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 Model Number72202901
Device Catalogue Number72202901
Device Lot Number50612828
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/16/2017
Initial Date FDA Received11/17/2017
Supplement Dates Manufacturer Received12/01/2017
03/01/2018
Supplement Dates FDA Received12/04/2017
03/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
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