MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, TI, 4.5 X 32MM; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW, TI, 4.5 X 32MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/05/2018
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.A portion of the device remains in the patient and the remaining portion was not returned.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during an ankle fusion case, the head of the screw ar-8545-32 popped off the base of the screw.The base of the screw remains in the patient.The screw had already been implanted; the surgeon was implanting another screw; per the rep who was present, the ar-8548-32 screw was in the compression hole and under pressure when the other screw was being inserted.The case was completed with no additional incisions needed.

• Brand Name: LOW PROFILE SCREW, TI, 4.5 X 32MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7713408
• Report Number: 1220246-2018-00566
• Device Sequence Number: 13733394
• Product Code: HRS
• UDI-Device Identifier: 00888867124547
• UDI-Public: 00888867124547
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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: LOW PROFILE SCREW, TI, 4.5 X 32MM
• Device Catalogue Number: AR-8545-32
• Device Lot Number: UNK1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/24/2018
• 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