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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. 1.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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ARTHROCARE CORP. 1.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number 25-1800
Device Problem Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2019
Event Type  malfunction  
Event Description
It was reported that during the mpfl procedure, when the anchor dial was turned, the implant would not deploy.No patient injury was reported.Backup device was used.10 minutes delay was reported.
 
Manufacturer Narrative
After further assessment of the complaint it was determinate that the event does not meet the criteria to be a reportable mdr complaint.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
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Brand Name
1.8MM Q-FIX ALL SUTURE ANCHOR
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
MDR Report Key8414419
MDR Text Key138922865
Report Number3006524618-2019-00142
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
PMA/PMN Number
K133727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/12/2019
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 Number25-1800
Device Lot Number2012433
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/21/2019
Initial Date FDA Received03/12/2019
Supplement Dates Manufacturer Received04/12/2019
Supplement Dates FDA Received04/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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