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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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ARTHREX, INC. FIBERTAK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE Back to Search Results
Model Number FIBERTAK
Device Problems Break (1069); Activation Failure (3270)
Patient Problem Failure of Implant (1924)
Event Date 11/29/2021
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On (b)(6) 2021, it was reported by an arthrex employee via email that an ar-3638 knotless fibertak implant inserter broke during insertion.This was discovered during a labral repair procedure on (b)(6) 2021, which produced debris and implant did not deploy.Surgeon re-drilled a new bone socket and was able to implant a new device.
 
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On (b)(6) 2021, it was reported by an arthrex employee via email that an ar-3638 knotless fibertak implant inserter broke during insertion.This was discovered during a labral repair procedure on (b)(6) 2021, which produced debris and implant did not deploy.Surgeon re-drilled a new bone socket and was able to implant a new device.
 
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Brand Name
FIBERTAK
Type of Device
FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key13053656
MDR Text Key286062281
Report Number1220246-2021-04119
Device Sequence Number1
Product Code MBI
UDI-Device Identifier00888867292123
UDI-Public00888867292123
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K130458
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFIBERTAK
Device Catalogue NumberAR-3638
Device Lot Number11198698
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/29/2021
Date Device Manufactured06/30/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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