MAUDE Adverse Event Report: ARTHREX, INC. 3 HOLE COMPRESSION PLATE; PLATE, FIXATION, BONE

Catalog Number	AR-8007-25
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	08/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, 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 for evaluation but was not returned 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.Device history record review revealed nothing relevant to this event.The most likely cause(s) of this type of event include non-compliance to the post-op protocol or post-op trauma to the surgical site.Per device directions for use (dfu-0192), 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.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.Device requested but not yet received.
Event or Problem Description
It was reported that plate broke post-op.Surgery performed was an arthrodesis navicular cuneiform medial.Breakage of the plate was observed approximately seven months after initial surgery.Patient did follow surgeon's instructions post-op.Patient had persisting swelling and pain, breakage of the plate was observed during x-ray control.Revision was performed on (b)(6) 2016 with a non-arthrex device.Outcome of revision surgery was good, patient is doing well.Patient is female, yob 1953.
Additional Manufacturer Narrative
Patient demographics (age at time of event, 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.This is a follow-up submission to reflect device evaluation.Complaint confirmed.The evaluation revealed the compression plate fractured through the adjustable arms near the two hole side of the plate.There is damage on the plate most likely due to impact from other devices during installation.Additionally there is damage on the bottom side of the plate near the fracture site and its origin is undetermined.There are faint striations on the fracture site which may indicate a cyclic component to the failure event.The most likely cause(s) for the complainant's event include in-vivo loading of the device combined with the following: stress risers from damage to the device during installation, bending/stressing the plate prior to implantation, and/or possible patient non-compliance with the post-op protocol.Per product directions for use, 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 plate broke post-op.Surgery performed was an arthrodesis navicular cuneiform medial.Breakage of the plate was observed approximately seven months after initial surgery.Patient did follow surgeon's instructions post-op.Patient had persisting swelling and pain, breakage of the plate was observed during x-ray control.Revision was performed on (b)(6) 2016 with a non-arthrex device.Outcome of revision surgery was good, patient is doing well.Patient is female, (b)(6).

• Brand Name: 3 HOLE COMPRESSION PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6073149
• Report Number: 1220246-2016-00469
• Device Sequence Number: 13471601
• Product Code: HRS
• UDI-Device Identifier: 00888867042513
• UDI-Public: 00888867042513
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2017

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-8007-25
• Device Lot Number: 1164845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 01/06/2017
• 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