MAUDE Adverse Event Report: ARTHREX, INC. FIBERSTITCH IMPLANT, CURVED; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number FIBERSTITCH IMPLANT, CURVED

Device Problems Break (1069); Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 12/31/2019

Event Type  Injury  

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 Description

It was reported that during a meniscal repair procedure, the surgeon was utilizing a fiberstitch implant, ar-4570, lot: 19k24.The surgeon was attempting to repair the medial meniscus on a patients left knee.Upon inserting the ar-4570 device utilizing the ar-4505 portal skid into the medial portal, selecting the implant location and beginning the process of repairing the meniscus the following took place: the meniscus was penetrated with the device, and the depth stop set to 18mm.The device was inserted so that the depth stop made contact with the meniscus and then the toggle was rolled toward the surgeon until an audible click was heard and the first implant was deployed.The toggle was then rolled all the way forward and the device was removed from the meniscus.After selecting a second location and penetrating the meniscus, the toggle switch was rolled toward the surgeon for a second time, however the device toggle switch would not roll easily.The surgeon was able to force the toggle switch, with some difficulty, to be rolled completely toward him, in the exact same manner as the first implant.The device did not give an audible click.The surgeon rolled the toggle completely forward and removed the device from the meniscus to reveal that the second implant had not been delivered from the device.The surgeon attempted to roll the toggle switch toward him again with the device in full view.Nothing happened and it appeared the second implant was stuck in the device.Upon removing the device from the patient by pulling back on the device, the suture remained in the patient, attached to the first implant.The surgeon slid the ar-5815 over the suture and cut the remaining suture out of the patient.Attempting a second device ar-4570 lot: 19k24 (second device of the same lot) in the same manner as the first, the exact same steps were repeated and same mode of failure was observed.Both devices were kept and will be returned for evaluation when shipping information is provided.A total of 10 minutes of operative time were taken to utilize both devices and remove them.A competitive product was used in place of the ar-4570 and the procedure was completed as planned.The patient was (b)(6) years old and tissue quality was healthy and not calcified.The repair was taking place on the posterior horn of the medial meniscus.It should be noted that later on in the procedure, qty: 2, ar-4570 lot: 19k24 (third and fourth device from same lot) were used to repair a mid-body tear of the medial meniscus and performing the same steps listed above, the devices functioned as expected and good repair of the meniscus was obtained.Additional information provided 1/3/2019: the first implants were not removed from the capsule and remained in the patient.

• Brand Name: FIBERSTITCH IMPLANT, CURVED
• Type of Device: 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: 9607437
• MDR Text Key: 189497231
• Report Number: 1220246-2020-01592
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10818674021798
• UDI-Public: 10818674021798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: FIBERSTITCH IMPLANT, CURVED
• Device Catalogue Number: AR-4570
• Device Lot Number: 19K24
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2019
• 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
• Patient Outcome(s): Other