MAUDE Adverse Event Report: ARTHREX, INC. CANNULATED SCREW, 3.75 X 34 MM PT THREADED; SCREW, FIXATION, BONE

Catalog Number	AR-7000-34
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/04/2017
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.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Lot number was not provided so device history record review cannot be performed.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.Device reported to be discarded.
Event or Problem Description
It was reported that ten days post-op after a left laterjet procedure, patient was seen by surgeon for a post-op check up with complaints of pain in the left shoulder.Films were taken and it was discovered that the ar-7000-34, 3.75x34mm partially threaded cannulated screw ((b)(6) (b)(6)) was broken into two pieces.Revision surgery took place the following day where the surgeon explanted the two pieces of the 3.75x34mm partially threaded cannulated screw ((b)(4)).A 3.75x32mm partially threaded cannulated screw ((b)(6) (b)(4)) was also removed but was not broken.The surgeon replaced both with a second 3.75x34mm partially threaded cannulated screw and a second 3.75x32mm partially threaded cannulated screw.No lot information was available.

• Brand Name: CANNULATED SCREW, 3.75 X 34 MM PT THREADED
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6282311
• Report Number: 1220246-2017-00002
• Device Sequence Number: 675656
• Product Code: HWC
• UDI-Device Identifier: 00888867041042
• UDI-Public: 00888867041042
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K103705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/27/2017

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-7000-34
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-7000-32 CANNULATED SCREW 3.75 X 32 MM
• Outcome Attributed to Adverse Event: Other