MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE FRACTURE PLATE, CENTRAL THIRD, LEFT, STAINLESS STEEL; PLATE, FIXATION, BONE

Catalog Number	AR-2654CL
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth) 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 contribution of the device to the event as reported could not be determined as the device was not returned for evaluation.Device history record review revealed nothing relevant to this event.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.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 the patient had a primary clavicle procedure in (b)(6) 2016 with an arthrex clavicle plate, and it was successful.Two months post-op, imaging was performed and showed that the clavicle plate was bent.The surgeon decided to leave it in to give it time to heal.The clavicle plate was removed on (b)(6) 2017.The plate was bent, and the patient had a non-union.The surgeon used another manufacturer's plate to complete this procedure successfully.
Additional Manufacturer Narrative
Patient demographics (date of birth) 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 due to device evaluation.Complaint confirmed.The device met all material specifications as received.The evaluation revealed the returned plate is bent.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.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 a primary clavicle procedure in (b)(6) 2016 with an arthrex clavicle plate, and it was successful.Two months post-op, imaging was performed and showed that the clavicle plate was bent.The surgeon decided to leave it in to give it time to heal.The clavicle plate was removed on (b)(6) 2017.The plate was bent, and the patient had a non-union.The surgeon used another manufacturer's plate to complete this procedure successfully.

• Brand Name: CLAVICLE FRACTURE PLATE, CENTRAL THIRD, LEFT, STAINLESS STEEL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6321832
• Report Number: 1220246-2017-00015
• Device Sequence Number: 16434018
• Product Code: HRS
• UDI-Device Identifier: 00888867027466
• UDI-Public: 00888867027466
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112437
• 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,Followup
• Report Date (Section B): 03/10/2017

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-2654CL
• Device Lot Number: 6791310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/10/2017
• 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: 38 YR
• Patient Weight: 59