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

Model Number	HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 5/19/2022, it was reported by a sale representative via email that an ar-3602h hip fibertak suture anchor inserter broke.The anchor was successfully implanted and all broken fragments retrieved.This was discovered during an hip acetabulum repair on (b)(6) 2022.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified inserter shaft, hip fibertak, suture tape tip was broken off.The other one had a shaft bent but no breakage.The last one did not show damage.No suture or anchor was received.The cause remains undetermined.However, the most likely reasons are improper bone prep, misaligned insertion, and prying and leveraging the device.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14602964
• Report Number: 1220246-2022-05029
• Device Sequence Number: 5562671
• Product Code: MBI
• UDI-Device Identifier: 00888867295520
• UDI-Public: 00888867295520
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: 06/30/2026
• Device Model Number: HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
• Device Catalogue Number: AR-3602H
• Device Lot Number: 13775326
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown