MAUDE Adverse Event Report: ARTHREX, INC. SELF BUNCHING KL 1.8 FIBERTAK, HIP; NON-DEGRADABLE FIXATN FASTENER

Model Number SELF BUNCHING KL 1.8 FIBERTAK, HIP

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2024

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 4/5/2024, it was reported by a sales representative via phone that an ar-3636h self bunching 1.8 knotless hip fibertak soft anchor had an issue during a hip scope procedure on (b)(6) 2024.When the surgeon was trying to insert the anchor into the patient's hard bone, the anchor was seated correctly, but when removing the inserter, the tip had broken broken off inside the patient at about 1 inch and a half's length.The surgeon was able to remove the anchor as well as the inserter tip from the patient, nothing was left inside the patient.The case was being completed by using four ar-3636h with different lot numbers 15164260 with no issues.The case was still ongoing while the complaint was being reported, but had been delayed for over 15 minutes, and additional anesthesia was administered to the patient.There was no adverse effect to the patient.The complaint device was discarded due to contamination but pictures will be provided via email.The sales representative stated that the surgeon was about to close up the patient and finish the case.This occurred during use with no patient harm.Additional information has been requested.On 4/5/2024, the sales representative confirmed via email that the case was completed successfully.

• Brand Name: SELF BUNCHING KL 1.8 FIBERTAK, HIP
• Type of Device: NON-DEGRADABLE FIXATN 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: 19203821
• MDR Text Key: 342005692
• Report Number: 1220246-2024-02572
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867362888
• UDI-Public: 00888867362888
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Model Number: SELF BUNCHING KL 1.8 FIBERTAK, HIP
• Device Catalogue Number: AR-3636H
• Device Lot Number: 15175699
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1