MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, TI, 4.5 X 26MM; PLATE, FIXATION, BONE

Catalog Number	AR-8545-26
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.Complaint confirmed.The returned device met all material specifications as received.The evaluation revealed that the distal side of the screw head displayed evidence of a tension/compression break on the fracture line.The complainant's event typically occurs due to leveraging during insertion, improper bone preparation and or by continually applying torque after the screw is fully seated.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the 4.5 mm x 26 mm titanium low profile screw was being used in an ankle fusion anterior right procedure.When screwing in this last screw, once it was seated, the head of the screw came off.Threads remained in the plate and in the patient.The screw head was removed from the patient and returned for evaluation.The quick connect start driver was used to screw in the low profile screw.Patient, female, (b)(6)y/o.

• Brand Name: LOW PROFILE SCREW, TI, 4.5 X 26MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6352228
• Report Number: 1220246-2017-00044
• Device Sequence Number: 11013398
• Product Code: HRS
• UDI-Device Identifier: 00888867124486
• UDI-Public: 00888867124486
• 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): 02/23/2017

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-8545-26
• Device Lot Number: K141735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/23/2017
• 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: 39 YR