INTERNALBRACE LIGAMENT AUGMENTATION KIT AR-1678-CP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for INTERNALBRACE LIGAMENT AUGMENTATION KIT AR-1678-CP manufactured by Arthrex, Inc..

Event Text Entries

[146950810] Underwent a brostrom repair on (b)(6) 2017 to treat instability of the ankle. Md used arthrex internalbrace ((b)(4)) to reinforce repair. The device was used in an off label manner, splitting the suture into a v (fibula-talus and fibula-calcaneus). Initial results were god, including post-physical therapy range of motion and strength. However, i was unable to return to exercise as i experienced pain 2-3 days after each attempt. Additionally, the atfl and cfl slowly returned to their pre-procedure laxity. By (b)(6) 2019 i was experiencing near chronic pain at levels higher than per-procedure. Therefore, i sought additional treatment from a different md. She recommended undergoing a second brostrum procedure, which took place (b)(6) 2019. During the procedure she removed a large amount of scar tissue within the joint space and around the original repair site. The original anchors were visualized. All three were well seated below the bone surface, with suture material exiting each anchor. The suture material was no longer in continuity between the anchors. Both strips had broken, activity levels between procedures, apart from physical therapy, are best described as primarily sedentary with <10 sessions of exercise (activities included cycling, indoor rower, and light weights. ) surgical revision. Weight at time of original procedure: (b)(6) lb. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5087068
• MDR Report Key: 8659375
• Date Received: 2019-05-30
• Date of Report: 2019-05-27
• Date of Event: 2019-05-10
• Date Added to Maude: 2019-05-31
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: INTERNALBRACE LIGAMENT AUGMENTATION KIT
• Generic Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Product Code: MAI
• Date Received: 2019-05-30
• Model Number: AR-1678-CP
• Catalog Number: AR-1678-CP
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARTHREX, INC.

Device Sequence Number: 2

• Brand Name: INTERNALBRACE LIGAMENT AUGMENTATION KIT
• Generic Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Product Code: MAI
• Date Received: 2019-05-30
• Model Number: AR-1688-CP
• Catalog Number: AR-1688-CP
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ARTHREX, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-05-30