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

Catalog Number	AR-8545-32
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/31/2017
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.The device was requested/is expected but was not returned for evaluation.Therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.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.Per customer screw head not returning.
Event or Problem Description
It was reported that the 4.5 mm x 32 m titanium low profile screw, ar-8545-32, was being used in an ankle fusion with an anterior plate.The bone was prepared by using a 3.0 mm drill.The screw was being inserted into the patient by using a t-20 driver.While the screw was being inserted by hand into the bone the screw snapped.No extra torque was involved.The screw head snapped-off as the plate was being brought down to the bone.The screw head was retrieved from the patient but the screw shaft was left fully inserted into the tibia.The procedure was completed successfully.No patient injury reported.

• Brand Name: LOW PROFILE SCREW, TITANIUM, 4.5 X 32 MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6349017
• Report Number: 1220246-2017-00034
• Device Sequence Number: 552369
• Product Code: HRS
• UDI-Device Identifier: 00888867124547
• UDI-Public: 00888867124547
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/22/2017

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-8545-32
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 02/22/2017
• 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
• Patient Age: 68 YR