MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,PT THD,TI,5.5MMX 55MM; SCREW, FIXATION, BONE

Catalog Number	AR-9055-55PT
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/28/2016
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.Complaint not confirmed.The device met all material specification as received.The evaluation revealed that the returned screw's hex was stripped and minor scratches were observed on the non-threaded area, possibly caused during the device removal.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.Lot number was not provided so device history record review cannot be performed.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported by the patient's father that his son had undergone a 5th metatarsal jones fracture procedure on (b)(6) 2016.The screw was placed on the left outer side of the patient's foot.The patient has been experiencing pain in his foot with an inability to bend his toe.Patient had 2 mri's taken which patient's father reports indicates a possibility of blood passing through at the screw head which surgeon reported to him could possibly indicate the screw might be backing out slightly however surgeon stated this could not be confirmed until the revision surgery takes place.Patient states surgeon indicated that it appears from mri/x-rays that the fracture itself is healed.Patient was referred to a new surgeon by his previous surgeon.Patient underwent a revision surgery (b)(6) 2016, performed by the second surgeon at a different facility, to remove the arthrex screw.Reporter states the surgeon informed him that the area around the screw head appeared to missing some material.No further information was available.The device has been requested for evaluation.

• Brand Name: LO-PRO SCRW,PT THD,TI,5.5MMX 55MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6267706
• Report Number: 1220246-2016-00609
• Device Sequence Number: 393343
• Product Code: HWC
• UDI-Device Identifier: 00888867056954
• UDI-Public: 00888867056954
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K123242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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-9055-55PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 01/20/2017
• 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