MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, HIP PUSHLOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1923PHS

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Rupture (2208); Osteolysis (2377); Reaction (2414)

Event Date 01/09/2013

Event Type  Injury  

Event Description

It was reported that the surgeon secured the capsule because it was torn (ruptured).The patient was having an inflammatory reaction (osteolysis) to the peek anchor.Mri showed an inflammatory process to the bone.Case: revision of the labrum.Follow-up information: pt had a right (labrum repair) hip procedure with a peek anchor kit and the capsule was sutured with #2 vicryl sutures (another manufacturer's).She had an mri done and has an inflammation of her bone in the area of the implant.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, 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.The device was requested for evaluation but part remains in the patient and cannot be returned 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.Lot number was not provided so device history record review cannot be performed.Another manufacturer's device(s) was also used for the fixation which may have contributed to the event as well.The most likely cause of this type of event is an adverse reaction of the patient to the material(s) implanted.Product directions for use warns of adverse effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to device materials must be considered prior to implantation.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.

• Brand Name: SUTURE ANCHOR, HIP PUSHLOCK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4011903
• MDR Text Key: 4691527
• Report Number: 1220246-2014-00141
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2014

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 Catalogue Number: AR-1923PHS
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2013
• Initial Date FDA Received: 08/15/2014
• 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