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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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ARTHROCARE CORP. MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Model Number 72290002
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2018
Event Type  malfunction  
Event Description
It was reported that the screw was still attached after it disengaged from the implant.A competitors implant (interference screw) was inserted over the eyelet of the s&n device to lock up the tension and secure the repair.No patient injury or other complications were reported.
 
Manufacturer Narrative
The reported multifix s- ultra device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.An exact root cause cannot be determined without evaluating the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force applied.Or (2) levering the device during insertion.Excessive force or levering the product during or after insertion can result in damage to the product.
 
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Brand Name
MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer (Section G)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer Contact
jim gonzales
7000 w. william cannon dr.
austin, TX 78735
MDR Report Key7358770
MDR Text Key103414096
Report Number3006524618-2018-00142
Device Sequence Number1
Product Code MBI
UDI-Device Identifier00885556614211
UDI-Public(01)00885556614211(17)190629(10)1155660
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132590
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/22/2018
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 Date06/29/2019
Device Model Number72290002
Device Catalogue Number72290002
Device Lot Number1155660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received03/21/2018
Supplement Dates Manufacturer Received05/17/2018
Supplement Dates FDA Received05/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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