MAUDE Adverse Event Report: ARTHREX INC. DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS; WASHER, BOLT NUT

Catalog Number	AR-2657DR
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	11/19/2017
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.The device was requested/is expected for evaluation but has not yet been received.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 patient non-compliance to the post-op protocol or post-op trauma to the surgical site.The directions for use for the device states: post-operatively and 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 post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the distal clavicle plate broke post-op.Initial surgery was on (b)(6) 2017.Revision surgery was done on (b)(6) 2017.Follow-up investigation: the clavicle plate broke 2 weeks post-op, the patient was in the shower and heard a snap.Patient did not fall and was not under trauma.The surgeon assures that the patient was compliant with the post-op guidelines.Patient: male, (b)(6).On the revision surgery the broken implant was completely removed and a new implant - ar-2653cr was implanted.
Event or Problem Description
It was reported that the distal clavicle plate broke post-op.Initial surgery was on (b)(6) 2017.Revision surgery was done on (b)(6) 2017.Follow-up investigation: the clavicle plate broke 2 weeks post-op, the patient was in the shower and heard a snap.Patient did not fall and was not under trauma.The surgeon assures that the patient was compliant with the post-op guidelines.Patient: male, (b)(6).On the revision surgery the broken implant was completely removed and a new implant - ar-2653cr was implanted.
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 due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the plate broke diagonally towards the tapered end at the second locking hole.Fracture surface was rough with little deformation which is typical in metal mechanical fracture as result of bending stress.The most likely cause(s) of this type of event include patient non-compliance to the post-op protocol or post-op trauma to the surgical site.The directions for use for the device states: post-operatively and 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 post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

• Brand Name: DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7147517
• Report Number: 1220246-2017-00493
• Device Sequence Number: 16375497
• Product Code: HTN
• UDI-Device Identifier: 00888867027534
• UDI-Public: 00888867027534
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• 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): 02/22/2018

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-2657DR
• Device Lot Number: 67251303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/22/2018
• 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: 110