MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5 MM; SCREW, FIXATION, BONE

Catalog Number	AR-1926PS
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Toxicity (2333)
Date of Event	12/22/2006
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 1220246-2017-00067 ((b)(4)).The device was not returned for evaluation but remained in the patient 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 likely cause of this type of event is a reaction of the patient to the material(s) implanted.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 device materials must be considered prior to implantation.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 remains in patient.
Event or Problem Description
A patient submitted a request through the arthrex website for material composition of the arthrex bio fastac screw and push lock anchors.Patient is seeking material composition because the products were used in her shoulder surgery.Recent tests show she is allergic to nickel and many other products and patient states she may have to have the implants removed.**additional information obtained 2/17/2017: patient's surgery was a left slap lesion type 2 procedure which took place (b)(6) 2006.Patient has been experiencing pain, burning and aching since day after surgery.No cultures have been taken and she has been treated with pain meds for the symptoms.No revision surgery has been planned.During the (b)(6) 2006 procedure patient states the following arthrex screws were implanted: ar-1926ps pushlock, lot 95580 (qty 2) ((b)(4)), ar-1926ps pushlock, lot 102736 (qty 1) ((b)(4)) and a biofastac screw 3.5 mm (specific part/lot number not provided - unable to locate possible product sale to facility).

• Brand Name: SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5 MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6398547
• Report Number: 1220246-2017-00068
• Device Sequence Number: 47450
• Product Code: HWC
• UDI-Device Identifier: 10888867023335
• UDI-Public: 10888867023335
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/13/2017

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: 09/01/2011
• Device Catalogue Number: AR-1926PS
• Device Lot Number: 102736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/13/2017
• 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