MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE FRACTURE PLATE; PLATE, FIXATION, BONE

Catalog Number	AR-2652CL
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	11/11/2016
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.The contribution of the device to the event as reported could not be determined as the device was not returned for evaluation.It was stated in the event that after the procedure, while the patient was driving, he felt a pop which was followed by pain and swelling.The plate broke in half.A revision surgery was performed (within 5 weeks of the initial surgery.The most likely cause of this event is patient non-compliance and failure to follow the post-op rehab protocol.The directions for use states: post-operatively, 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 implant.Device history record review revealed nothing relevant to this event.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.Unknown device disposition.
Event or Problem Description
It was reported that the patient had an orif clavicle fx procedure performed on (b)(6) 2016 which was completed successfully with a left ss central third clavicle fracture plate ((b)(4)).After the procedure, while the patient was driving, he felt a pop which was followed by pain and swelling.The plate broke in half.A revision surgery was performed on (b)(6) 2016.At that time, the broken plate and screws were removed from the patient.Another left ss central third clavicle fracture plate was used to complete the procedure successfully.In the process of removing the plate, the surgeon also removed the following screws: 3.5mm x 8mm ss low profile screw ((b)(4)), 3.5mm x 12mm tm ss cortical low profile screw ((b)(4)), 3.5mm x 18mm ss tm cortical low profile screw ((b)(4)), 3.5mm x 12mm ss low profile locking screw ((b)(4)), 3.5mm x 14mm ss low profile locking screw ((b)(4)), 3.5mm x 18mm ss low profile locking screw ((b)(4)).Bone quality: good.
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 a follow-up submission for device evaluation.Complaint confirmed.The device met all material specification as received.The evaluation revealed that the plate was broken in half.The fracture face is located approximately at the plate's midpoint and runs from one of the central oblong holes through the adjoining suture hole.Features observed on the fracture surface are typically seen on metal fracture due to metal fatigue from bending stress that exceeded the fatigue strength of the material.In addition, presence of worn out or post-fracture rubbing damage areas is indicative of low cycle fatigue fracture mode.Based on the event description and observed evidence, the most likely cause for the complainant's event was in-vivo loading of the device possibly causing a fatigue fracture and/or patient non-compliance with the post-op protocol.Per product directions for use (dfu-0192), post-operatively, until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.Device history record review revealed nothing relevant to this event.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 patient had an orif clavicle fx procedure performed on (b)(6) 2016 which was completed successfully with a left ss central third clavicle fracture plate ((b)(4)).After the procedure, while the patient was driving, he felt a pop which was followed by pain and swelling.The plate broke in half.A revision surgery was performed on (b)(6) 2016.At that time, the broken plate and screws were removed from the patient.Another left ss central third clavicle fracture plate was used to complete the procedure successfully.In the process of removing the plate, the surgeon also removed the following screws: 3.5mm x 8mm ss low profile screw ((b)(4)), 3.5mm x 12mm tm ss cortical low profile screw ((b)(4)), 3.5mm x 18mm ss tm cortical low profile screw ((b)(4)), 3.5mm x 12mm ss low profile locking screw ((b)(4)), 3.5mm x 14mm ss low profile locking screw ((b)(4)), 3.5mm x 18mm ss low profile locking screw ((b)(4)).Bone quality: good.

• Brand Name: CLAVICLE FRACTURE PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6150581
• Report Number: 1220246-2016-00545
• Device Sequence Number: 13533983
• Product Code: HRS
• UDI-Device Identifier: 00888867027428
• UDI-Public: 00888867027428
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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-2652CL
• Device Lot Number: 5261607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-8835-12, LOT 95241614, LO-PRO SCREW; AR-8835-18, LOT 95241614, LO-PRO SCREW; AR-8835L-12, LOT D64603, LO-PRO LOCKING SCREW; AR-8835L-14, LOT 10016033, LO-PRO LOCKING SCREW; AR-8835L-18, LOT 1382955, LO-PRO LOCKING SCREW
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR