MAUDE Adverse Event Report: ARTHREX, INC. PLATE, FIXATION, BONE; RETROFUSION SCREW, 24MM

Catalog Number	AR-4157-24
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/29/2017
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 improper bone preparation, over-torquing or leveraging the implant during insertion.The potential cause(s) of this event will be 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 during a hammer toe repair procedure, the surgeon drilled to appropriate depth and went to insert the 24 mm retrofusion screw (lot: 10052898), as the surgeon began to torque, the head of the screw snapped off.The proximal portion of the screw was left in the patient's bone sitting proud in the joint.The surgeon cleaned out around the shaft of the screw and used a needle driver as well as pliers to try and get a grip of the screw however, was unsuccessful at retrieving the fragment.The surgeon moved on and implanted two k-wires to pin the joint in place.15-20 min delay in case.Patient is a (b)(6) male.The surgeon has not yet stated whether or not he would like to go in at a later date to try and retrieve the screw.Follow-up investigation: as of today the surgeon is not planning on retrieving the screw fragment from the patient.
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 due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the returned 24mm retrofusion implant broke off at the proximal end.The fracture surface displays evidence of torsional-overload.The device met all material specifications as received.The most likely cause(s) of this type of event include improper bone preparation, over-torquing or leveraging the implant during insertion.The potential cause(s) of this event will be 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 during a hammer toe repair procedure, the surgeon drilled to appropriate depth and went to insert the 24mm retrofusion screw (lot: 10052898), as the surgeon began to torque, the head of the screw snapped off.The proximal portion of the screw was left in the patient's bone sitting proud in the joint.The surgeon cleaned out around the shaft of the screw and used a needle driver as well as pliers to try and get a grip of the screw however, was unsuccessful at retrieving the fragment.The surgeon moved on and implanted two k-wires to pin the joint in place.15-20 min delay in case.Patient is a (b)(6) y/o male.The surgeon has not yet stated whether or not he would like to go in at a later date to try and retrieve the screw.Follow-up investigation: as of today the surgeon is not planning on retrieving the screw fragment from the patient.

• Brand Name: PLATE, FIXATION, BONE
• Common Device Name: RETROFUSION SCREW, 24MM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6714756
• Report Number: 1220246-2017-00256
• Device Sequence Number: 19046351
• Product Code: HRS
• UDI-Device Identifier: 00888867193932
• UDI-Public: 00888867193932
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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 Expiration Date: 06/01/2021
• Device Catalogue Number: AR-4157-24
• Device Lot Number: 10052898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/16/2017
• 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: 17 YR