MAUDE Adverse Event Report: ARTHREX INC. 3.0 X 20MM VARIABLE ANGLE LOCKING SCREW, TI; SCREW, FIXATION, BONE

Catalog Number	AR-8933V-20
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/27/2017
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.Lot number was not provided so device history record review cannot be performed.Complaint confirmed.The evaluation revealed that the two screws were broken-off.The screws met all material specifications as received.The surgeon stated that the patient was non-compliant.The most likely cause of this event is 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.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 patient complained about pain in the surgical area.The surgeon found out that 2 screws broke post-op.On the revision surgery the plate and screws were completely removed and a new plate was implanted.According to the surgeon the patient was non-compliant to the post-op guidelines.
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 to correct the awareness date which should have been 01/29/2018 and not 01/16/2018 for this report.Lot number was not provided so device history record review cannot be performed.Complaint confirmed.The evaluation revealed that the two screws were broken-off.The screws met all material specifications as received.The surgeon stated that the patient was non-compliant.The most likely cause of this event is 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.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 patient complained about pain in the surgical area.The surgeon found out that 2 screws broke post-op.On the revision surgery the plate and screws were completely removed and a new plate was implanted.According to the surgeon the patient was non-compliant to the post-op guidelines.

• Brand Name: 3.0 X 20MM VARIABLE ANGLE LOCKING SCREW, TI
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7273909
• Report Number: 1220246-2018-00047
• Device Sequence Number: 135575
• Product Code: HWC
• UDI-Device Identifier: 00888867050259
• UDI-Public: 00888867050259
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K103705
• 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): 07/23/2018

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-8933V-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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