MAUDE Adverse Event Report: ARTHREX, INC. PLT,LO-PRO,FLAT TI; PLATE, FIXATION, BONE

Model Number	PLT,LO-PRO,FLAT TI
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by the patient that she underwent a left foot tendon repair with bone marrow aspiration on (b)(6) 2019.During the procedure the patient states that an arthrex l-plate and screws were implanted along with a wedge and graft.Patient stated one of the screws has broken, leaving the top portion loose in the foot.Patient is having tremendous pain and the breakage will result in needing a second procedure.The patient only had two of the screw part numbers at time of report, ar-8724-16 (qty 1) and ar-8724-14 (qty 2).It is unknown if one of these two screws may be the broken one of if there may be other screws that were also implanted patient will reach out to the surgical facility to obtain the implant log and provide to arthrex upon receipt.Patient also reported that she had rolled her ankle at her home (rental) and reported it to her landlord and reported the now discovered broken screw issue.Landlord stance on the issue was that rolling her ankle should not cause the screw to break because titanium should not break, landlord instructed patient to contact the manufacturer (arthrex).Updated information obtained 7/22/2019: patient is still attempting to obtain the remaining part numbers.Patient is scheduled for revision surgery on (b)(6) 2019.Updated information obtained 8/7/2019: the primary case took place on (b)(6) 2019.During the primary case the surgeon implanted a low profile flat plate (ar-13200m, lot unknown), three screws (ar-8724-16 qty 1 lot unknown and ar-8724-14 qty 2, lots unknown) and a 3.0mm bio-composite suturetak (ar-8934bcnf lot unknown).The removal procedure took place on (b)(6) 2019 at the same facility with the same surgeon.Surgeon removed the plate and three screws.The bio-composite suturetak was left in the patient.The explanted ar-8724-16 was broken and the tip of it was buried into the bone enough that the surgeon decided to leave that portion of the screw in the patient.The surgeon gave the removed hardware to the patient at the patient's request.Facility informed the sales rep that the patient fell post operatively and that surgeon believes that may have been what caused the screw breakage.

• Brand Name: PLT,LO-PRO,FLAT TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8930593
• Report Number: 1220246-2019-01274
• Device Sequence Number: 18904900
• Product Code: HRS
• UDI-Device Identifier: 00888867008922
• UDI-Public: 00888867008922
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K040907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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 Model Number: PLT,LO-PRO,FLAT TI
• Device Catalogue Number: AR-13200M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/26/2019
• 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