MAUDE Adverse Event Report: ARTHREX, INC. CANNULATED SCREW,3.75X 32 MM PT THREADED; SCREW, FIXATION, BONE

Catalog Number	AR-7000-32
Health Effect - Clinical Code	Seizures (2063)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (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 the first of two submissions for the same patient event.The other is 1220246-2016-00569 ((b)(4)).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.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.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.Facility risk manager will not release.
Event or Problem Description
It was reported that the patient underwent a left laterjet procedure on (b)(6) 2016, where a 3.75x32mm cannulated partially threaded screw (ar-7000-32, lot: 1457740, (b)(4)) was implanted along with a 3.75x30mm cannulated partially threaded screw (ar-7000-30, lot: 1457565, (b)(4)).On an unknown date, the patient suffered from a seizure causing the ar-7000-32 to bend.A revision surgery took place on (b)(6) 2016 and the patient had the ar-7000-32, lot: 1457740, explanted and replaced with an ar-7000-34, lot: 1457742.The ar-7000-30, lot: 1457565, was also explanted and replaced with an ar-7000-32, lot: 10034143.Patient is a (b)(6) female.No patient injury.

• Brand Name: CANNULATED SCREW,3.75X 32 MM PT THREADED
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6173241
• Report Number: 1220246-2016-00568
• Device Sequence Number: 10850201
• Product Code: HWC
• UDI-Device Identifier: 00888867041011
• UDI-Public: 00888867041011
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K103705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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-7000-32
• Device Lot Number: 1457740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/14/2016
• 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: 25 YR