MAUDE Adverse Event Report: ARTHREX, INC. INTERNALBRACE LIGAMENT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1688-CP

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Part remained in the patient.

Event Description

It was reported that during an ankle reconstruction ligament with graft procedure, the surgeon was attempting to use the internal brace ligament kit.The tip of the 4.75mm talus suture anchor broke upon insertion.The tip of the anchor was left in patient's talus.The fiber tape was cut flush since it was tightly lodged within the talus.It would not be pulled out, therefore it was cut flush.This anchor was used to complete the procedure.The portion of the anchor remaining in the patient is approximately 2-3 mm.Surgeon did not see a crack in the anchor and noted the anchor was loosened from the driver.No additional unplanned anchors were used to complete the procedure.No unplanned incisions were made.

• Brand Name: INTERNALBRACE LIGAMENT
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6120171
• MDR Text Key: 60647205
• Report Number: 1220246-2016-00521
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: AR-1688-CP
• Device Lot Number: 300640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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
• Patient Age: 59 YR