MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK PUSH-LOCK 2.9 X 12.5 MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-2923PS
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	11/01/2016
Type of Reportable Event	Serious Injury
Additional 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.This is one of two submissions for the same patient event.The other is 1220246-2017-00161 ((b)(4)).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.Device history record review revealed nothing relevant to this event.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.This is the first complaint of this type for this part/lot combination.If additional relevant information is received, a follow-up report will be submitted.Part remains in patient.
Event or Problem Description
It was reported that the patient underwent a labrum repair on her left shoulder on (b)(6) 2016.About 2 weeks post-op, she started to notice hives on her left shoulder.She informed her surgeon, who advised her to see her family doctor.She was prescribed prednisone and adorac and has also been applying an anti-itch cream to alleviate the symptoms of the hives.The hives come and go, start at the surgery site and spreads up to the back of her neck.Allergy tests have been taken with negative results.The patient has a total of 3 pushlocks in her shoulder, ar-2923ps lot 1138636 qty 1 ((b)(4)) and ar-2923 lot 895132 qty 2 ((b)(4)).

• Brand Name: SUTURE ANCHOR, PEEK PUSH-LOCK 2.9 X 12.5 MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6555589
• Report Number: 1220246-2017-00160
• Device Sequence Number: 698881
• Product Code: MAI
• UDI-Device Identifier: 00888867028036
• UDI-Public: 00888867028036
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: AR-2923PS
• Device Lot Number: 1138636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other