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

Catalog Number	AR-8009-20
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Lot number was not provided so device history record review cannot be performed.As stated in the event, per surgeon ,the patient stated that he might have had too much weight on the foot too early.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, 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.Device expected but not yet received.
Event or Problem Description
It was reported that on (b)(6) 2016 the ar-8008-25, 4 hole double compression plate, was implanted.Approximately 5 (five) weeks after initial surgery, the plate broke post-op.A revision surgery was done on (b)(6) 2016 where an arthodesis was performed with compression screws.Per surgeon, the patient stated that he might have had too much weight on the foot too early.Bone quality unknown.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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 and a correction to the device part number.Complaint confirmed.The device met all material specification as received.The evaluation revealed the returned compression plate is broken in half.The fracture face displays plastic deformation.Per the complainant, the patient may have placed weight on the fracture site prematurely.The most likely cause(s) for the complainant's event include in-vivo loading of the device possibly causing a fatigue fracture and possibly in conjunction with bending/stressing the plate prior to implantation as well as patient non-compliance with the post-op protocol.Per product directions for use (dfu-0192), 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.Damage to the screw most likely occurred during plate extraction due to impact with another device.
Event or Problem Description
It was reported that on (b)(6) 2016 the ar-8008-25, 4 hole double compression plate, was implanted.Approximately 5 (five) weeks after initial surgery, the plate broke post-op.A revision surgery was done on (b)(6) 2016 where an arthodesis was performed with compression screws.Per surgeon, the patient stated that he might have had too much weight on the foot too early.Bone quality unknown.

• Brand Name: DOUBLE COMPRESSION PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6138118
• Report Number: 1220246-2016-00534
• Device Sequence Number: 13741767
• Product Code: HRS
• UDI-Device Identifier: 00888867042544
• UDI-Public: 00888867042544
• 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-8009-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• 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