MAUDE Adverse Event Report: ARTHREX, INC. HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP; NON-DEGRADABLE FIXATION FASTENER

Model Number	HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acetabular labral repair surgery when inserting the device, it could not stay in the bone.No part of the device broke off.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is not confirmed.One unpackaged ar-3602h-1 was received for investigation.Visual inspection identified that both the inserter and the suture tape were returned.No damage was noted to the inserter, nor to the suture construct.The investigation concluded without the observance of any abnormalities.No information was provided in terms of the method used to prepare the bone, as well as the bone quality encountered.

• Brand Name: HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
• Common Device Name: NON-DEGRADABLE FIXATION FASTENER
• 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: jared engle ; 8009337001
• MDR Report Key: 19312525
• Report Number: 1220246-2024-03257
• Device Sequence Number: 6911205
• Product Code: MBI
• UDI-Device Identifier: 00888867295537
• UDI-Public: 00888867295537
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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 Expiration Date: 01/31/2024
• Device Model Number: HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
• Device Catalogue Number: AR-3602H-1
• Device Lot Number: 10278021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown