MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 14MMCORT; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW TM,SS 3.5X 14MMCORT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2020
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 that a patient had a primary orif ankle fx performed on (b)(6) 2019, and was walking at 10 weeks.Without experiencing a new injury, the implanted arthrex plate broke and displaced the fx.The patient will need a second surgery.There was not an arthrex sales representative present during the initial case.10 week x-rays revealing the broken plate have been provided to arthrex.Additional information received on 03/20/2020: the rep provided the original sales order from the primary procedure.The following arthrex devices were implanted during the primary surgery; ar-8943t-10 // lot: 474735 x 1, ar-8835-14 // lot: 10266334 x 1, ar-8835-14 // lot: 10268858 x 1, ar-8835-14 // lot: 10273289 x 1, ar-8835-14 // lot: 10291574 x 1, ar-8835-16 // lot: 10221152 x 1, ar-8835-18 // lot: 10211116 x 1, ar-8835-18 // lot: 10223067 x 1, ar-8840-14 // lot: 10035722 x 1.At time of initial report to arthrex (march 9-2020) or when the additional information was provided, on march 20-2020, the sales rep did not have any additional details pertaining to the expected second surgery.Additional information obtained 5/13/20: there was a delay in obtaining information due to the covid-19 pandemic.The sales rep has now been able to confirm that the patient underwent a revision procedure on (b)(6) 2020 at a different facility.During the revision all original implants were explanted.Rep was unable to confirm if the procedure took place at the health system¿s hospital or the outpatient surgery center.The facility information for the hospital will therefore be used.There is no information provided regarding how the case was completed once the broken plate and screws were explanted.The disposition of the explanted devices is unknown.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 14MMCORT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10108635
• Report Number: 1220246-2020-01861
• Device Sequence Number: 11614560
• Product Code: HWC
• UDI-Device Identifier: 00888867047280
• UDI-Public: 00888867047280
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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: LO-PRO SCRW TM,SS 3.5X 14MMCORT
• Device Catalogue Number: AR-8835-14
• Device Lot Number: 10273289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other