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

Model Number FIBERSTITCH IMPLANT, CURVED

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

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 during an acl reconstruction with meniscal repair procedure, a quantity two ar-4570 fiberstitch implants from lot: 19k24 were implanted successfully.Upon trying to insert the third ar-4570 (lot: 19k24), the tip of the device broke.The broken tip was fully retrieved and removed from the patient by using a grasper.A fourth ar-4570 from the same lot was then brought in.The first implant deployed and implanted fine.The surgeon then attempted to implant the second implant, but upon removing the device from the joint the second implant came out with the device.The surgeon cut the suture of the first implant that was in the patient, and all portions of the first implant was removed from the joint.The rep stated the knee was very tight, and it was very difficult for the surgeon to move around within the joint.The surgeon switched to another manufacturers device to continue the procedure.However, the surgeon was still having issues with repairing the meniscus.The surgeon switched to meniscectomy, and removed a portion of the meniscus to complete the case.The first broken ar-4570 and retrieved tip will be returning for evaluation.The sales rep reported no unplanned incisions were made.

• 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: 9519444
• MDR Text Key: 173389268
• Report Number: 1220246-2019-01533
• 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: 12/26/2019

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
• 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?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/26/2019
• 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