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

Catalog Number	AR-4157-24
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/16/2016
Type of Reportable Event	Serious Injury
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.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.Device history record review revealed nothing relevant to this event.The most likely cause(s) of this type of event includes 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 second and third pip fusion case, the ar-4157-24 retrofusion screw, 24mm broke while attempting to insert in the second pip joint.Bony prep was followed per surgical technique.The screw was advanced in the proximal phalanx and was unable to advance further than 2/3 of proximal threads being in the im canal.K wire was taken circumferentially around screw in attempts to soften surrounding bone and remove screw but was unsuccessful.Since screw could not be removed, attempts were made to complete the insertion and the distal aspect of the screw broke at the smooth junction.The distal aspect of the screw was left in the patient but the proximal portion was retrieved.The second pip fusion was completed with a soft tissue reattachment only and the third pip fusion was completed with a k-wire.It was noted that the bone was prepared using ar-4157ds kit and the driver from the ar-4157ds was used for the implant screw.Patient was a (b)(6) male.

• 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: 6020451
• Report Number: 1220246-2016-00415
• Device Sequence Number: 902607
• Product Code: HRS
• UDI-Device Identifier: 00888867193932
• UDI-Public: 00888867193932
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/16/2016

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: 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: 10/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2016
• Initial Report FDA Received Date: 10/12/2016
• 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
• Patient Age: 60 YR