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

Catalog Number	AR-8545-40
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2016
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.This is the first of three submissions from the same patient event.The others are 1220246-2016-00381 ((b)(4)) and 1220246-2016-00382 ((b)(4)).Complaint confirmed.The device met all material specifications as received.The evaluation revealed the returned screw is broken in half with what appears to be a stress fracture.Lot number was not provided so device history record review cannot be performed.In the event, even though the surgeon points toward joint preparation and lack of posterior fixation as mode of implant failure, the following is applicable: per product directions for use (dfu-0125), post-operatively, until bone healing is complete, fixation given with this device should be considered as temporary and may not withstand weight bearing or other unsupported stress and until healing is complete the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.
Event or Problem Description
It was reported that an ankle fusion plate, anterior tt, right, ar-8970ar, lot 6791439, was implanted during a procedure on (b)(6) 2015.By the third follow up visit post-op, the health care provider noticed the distal locking screws in the talus were broken and began to loosen.On (b)(6) 2016, the patient underwent a revision procedure during which the broken screws ar-8545l-40 lot unknown ((b)(4)), ar-8545-38 lot unknown ((b)(4)) and ar-8555-60 lot unknown ((b)(4)) were removed.The screws are being returned for evaluation.Also explanted were the ankle fusion plate, anterior tt, right and the remaining screws all of which had no issue.These are also being returned with the broken screws.The surgeon used another manufacturer's ankle fusion device and biologics for the revision.The surgery outcome is unknown at this time.The surgeon suspects the locking mechanism may not have performed as expected.The surgeon also points toward joint preparation and lack of posterior fixation as mode of implant failure.

• Brand Name: LO-PRO SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5933818
• Report Number: 1220246-2016-00380
• Device Sequence Number: 472150
• Product Code: HRS
• UDI-Device Identifier: 00888867124622
• UDI-Public: 00888867124622
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/18/2016

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-8545-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2016
• Initial Report FDA Received Date: 09/07/2016
• 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: 73 YR