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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 09/11/2017
Event Type  malfunction  
Event Description
It was reported that suture anchor fell out inside of arthroscope.No patient injury was reported.
 
Manufacturer Narrative
One 72202901 footprint ultra pk 4.5 mm suture anchor returned.The device was used during a rotator cuff repair procedure.The complaint said ¿suture anchor fell out inside of arthroscope.¿ the anchor and one strand of suture were returned.The device does not show signs of aggressive use.The shaft is straight.The distal inner tip is undamaged and spins concentrically.A functional evaluation was performed and the torque limiter functioned as intended.Audible click was heard with advancement of the inner shaft.No root cause related to the manufacturing of this device was established.
 
Manufacturer Narrative
Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.No further actions pursued at this time.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.
 
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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 Key7038199
MDR Text Key92930834
Report Number1219602-2017-01426
Device Sequence Number1
Product Code MBI
UDI-Device Identifier03596010650528
UDI-Public(01)03596010650528(17)210401(10)50594366
Combination Product (y/n)N
PMA/PMN Number
K093897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup,Followup
Report Date 02/28/2018
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 Expiration Date04/01/2021
Device Model Number72202901
Device Catalogue Number72202901
Device Lot Number50594366
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2018
Initial Date Manufacturer Received 11/16/2017
Initial Date FDA Received11/16/2017
Supplement Dates Manufacturer Received01/01/2018
02/26/2018
Supplement Dates FDA Received01/03/2018
02/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2017
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 Age72 YR
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