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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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ARTHREX, INC. FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE Back to Search Results
Model Number FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
Health Effect - Clinical Codes Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/12/2021
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
It was reported that the tip of the ar-3602-2 anchor broke off in the bone after insertion.The case was completed by using another anchor.
 
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Brand Name
FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
Common Device Name
FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11602353
Report Number1220246-2021-02821
Device Sequence Number3683917
Product Code MBI
UDI-Device Identifier00888867206953
UDI-Public00888867206953
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K151230
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 04/01/2021
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
Operator of Device Health Professional
Device Model NumberFIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
Device Catalogue NumberAR-3602-2
Device Lot Number11114010
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2021
Initial Report FDA Received Date04/01/2021
Patient Sequence Number1
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