MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,LAT ANKLE RECON; SCREW, FIXATION, BONE

Model Number	IMPL SYS,LAT ANKLE RECON
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a lateral ankle reconstruction implant system, ar-1675bc-cp, was being used during a lateral ankle reconstruction procedure.The 5.5mm bio-tenodesis screw was being implanted into the lateral talus.Upon insertion, the surgeon missed the bone tunnel (that was prepared using 5.5mm reamer from the kit).He could not locate the screw in the joint and thinks that it may have went into/around the lateral aspect of the sinus tarsi.He made every attempt to locate and remove the screw but could not find it.He decided to leave it in the patient unsecured.The rest of the procedure was completed with no further incident.

• Brand Name: IMPL SYS,LAT ANKLE RECON
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8707149
• Report Number: 1220246-2019-01149
• Device Sequence Number: 19351083
• Product Code: HWC
• UDI-Device Identifier: 00888867020771
• UDI-Public: 00888867020771
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 05/31/2020
• Device Model Number: IMPL SYS,LAT ANKLE RECON
• Device Catalogue Number: AR-1675BC-CP
• Device Lot Number: 10220638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/18/2019
• 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