MAUDE Adverse Event Report: ARTHREX INC. IMPLANT SYSTEM,BIO-COMPOSITE ACHILLES MID-SUBSTANCE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-8929BC-CP

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problems Wound Dehiscence (1154); Pain (1994); Impaired Healing (2378)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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.This is one of two submissions from the same event.The other is (b)(4).Lot number was not provided therefore device history record review cannot be performed.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported by patient's spouse that the patient had an achilles speedbridge repair on (b)(6) 2017.The surgery site was not healing and a piece of yellow material (believed to be at least a portion of the banana suture lasso handle of the device) began to protrude out of patient's incision site.In (b)(6) 2017 during a follow up visit at surgeon's office the surgeon removed the yellow object in pieces by digging it out.Patient later had an extensive debridement performed by a different surgeon.Patient is reported to now have osteomyelitis as well.Follow-up investigation: original surgery took place on (b)(6) 2017, not (b)(6) 2017 as initially reported.During originally surgery the following devices were implanted: ar-8929bc-cp and ar-8860ds.Patient states that when reviewing his original surgeon office records he has discovered that there was no notation dealing with his august follow up during which the surgeon dug out the yellow pieces from his incision site.Patient noted that the pieces dug out were immediately discarded by the surgeon at his office and were not sent for evaluation or culture.Leading up to the august appointment the patient states his incision site was not healing and was draining fluid.He was experiencing pain and this yellow object would jut out from his incision when he flexed his foot down and when he flexed his foot back up it would retreat back into the incision.On (b)(6) 2017 the patient underwent an mri and a bone scan on (b)(6) 2017.On (b)(6) 2017 the second surgeon ordered a leukocyte image and patient had a bone scan leukocyte image performed on (b)(6) 2017.On (b)(6) 2017 patient had a second surgery to remove the original implants and an extensive debridement was performed.Second surgeon informed the patient that he was unable to remove one of the two peek eyelets from the original implant system because he was unable to locate it and felt he could damage the patient's bone by digging to look for it.Surgeon sent explanted devices to lab for culture/evaluation.

• Brand Name: IMPLANT SYSTEM,BIO-COMPOSITE ACHILLES MID-SUBSTANCE
• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7147520
• MDR Text Key: 95823579
• Report Number: 1220246-2017-00496
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867131651
• UDI-Public: 00888867131651
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-8929BC-CP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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