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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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ARTHREX, INC. HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE Back to Search Results
Model Number HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 08/27/2020
Type of Reportable Event Serious Injury
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 one of the metal fork tips on the inserter broke off during implant.They could not locate the tip with x-ray.The case was a hip labral repair.
 
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Brand Name
HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
Common Device Name
FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10517109
Report Number1220246-2020-02151
Device Sequence Number14241854
Product Code MBI
UDI-Device Identifier00888867295520
UDI-Public00888867295520
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K181769
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/31/2024
Device Model NumberHIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
Device Catalogue NumberAR-3602H
Device Lot Number10298673
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2020
Initial Report FDA Received Date09/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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