MAUDE Adverse Event Report: ARTHREX, INC. CANNULATED SCREW 3.75X 36MMFULLY THREADED; SCREW, FIXATION, BONE

Catalog Number	AR-7000-36FT
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
Additional 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.Lot number was not provided so device history record review cannot be performed.No device malfunction can be identified.At this time, it cannot be determined how the device may have caused or contributed to the incident.An evaluation of the device cannot be performed as the device remained in the patient.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.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.
Event or Problem Description
It was reported that on (b)(6) 2016, the patient underwent a total shoulder arthroplasty procedure, where a 3.75mm cannulated fully threaded screw was implanted into the right shoulder.On (b)(6) 2017, the patient was seen at east baptist outpatient where he underwent an mri on his right knee.After the second 15-second scan, the patient began to experience the screw in his shoulder heat up and stated that he felt like it had "torqued".There was no movement in the patient's shoulder and the patient will be following up with his surgeon.Patient is a (b)(6) male.

• Brand Name: CANNULATED SCREW 3.75X 36MMFULLY THREADED
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6724257
• Report Number: 1220246-2017-00268
• Device Sequence Number: 1291428
• Product Code: HWC
• UDI-Device Identifier: 00888867041080
• UDI-Public: 00888867041080
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K103705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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 Catalogue Number: AR-7000-36FT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/19/2017
• 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
• Patient Age: 34 YR