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

Catalog Number	AR-4157-20
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/11/2016
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.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 and/or over-torquing.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 during a procedure for a hammer toe (2nd toe), arthrocare resurfacing at mpt joint (2nd toe) and planta plate repair (3rd toe procedure the following occurred during the hammer toe (2nd toe) portion of the procedure.The surgeon was advancing the ar-4157-20 retro fusion 20 mm screw so that the distal threads would be against the proximal phalanx without engaging the threads into the bone and the screw broke on the proximal side of the screw end where the non threaded portion of the screw begins.The surgeon had no way to remove the remaining screw that was in the bone as there was no way to grab it.The broken screw was fully implanted into the bone with no portions extruding into the joint.The surgeon applied dbm to the prepped joint as best possible and closed the soft tissue with the toe in an extended position.Surgeon will treat conservatively to allow the bone to fuse straight.No patient injury reported.
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.Complaint confirmed.The device met all material specifications as received.The evaluation revealed that the returned retrofusion screw is broken at the proximal end.The fracture surface displays evidence of torsional-overload.The most likely cause(s) of this type of event include improper bone preparation and/or over-torquing.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 during a procedure for a hammer toe (2nd toe), arthrocare resurfacing at mpt joint (2nd toe) and planta plate repair (3rd toe procedure the following occurred during the hammer toe (2nd toe) portion of the procedure.The surgeon was advancing the ar-4157-20 retro fusion 20 mm screw so that the distal threads would be against the proximal phalanx without engaging the threads into the bone and the screw broke on the proximal side of the screw end where the non threaded portion of the screw begins.The surgeon had no way to remove the remaining screw that was in the bone as there was no way to grab it.The broken screw was fully implanted into the bone with no portions extruding into the joint.The surgeon applied dbm to the prepped joint as best possible and closed the soft tissue with the toe in an extended position.Surgeon will treat conservatively to allow the bone to fuse straight.No patient injury reported.

• Brand Name: RETROFUSION SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5935618
• Report Number: 1220246-2016-00383
• Device Sequence Number: 467563
• Product Code: HRS
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• 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): 09/20/2016

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: 07/20/2016
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10053198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2016
• Supplement Report FDA Received Date: 09/21/2016
• 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