MAUDE Adverse Event Report: ARTHREX INC. THREADED G-WIRE,W/TROCAR TIP,.062"; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-8941KT
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	12/20/2017
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.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.The potential causes of this event are being 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 mpfl/ tibial tubercle osteotomy procedure, the tip of the threaded guide pin broke-off into the tibia while the surgeon was placing it across the osteotomy for 4.5 mm lps fixation.The surgeon made no attempt to retrieve the tip of the pin and the tip was left in the patient.Patient is a female, (b)(6).Follow-up investigation: x-rays were taken to confirm device location.Device tip is embedded in the tibial tubercle.No pictures were available.The remaining portion of the guide pin was discarded and is not being returned for evaluation.

• Brand Name: THREADED G-WIRE,W/TROCAR TIP,.062"
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7178414
• Report Number: 1220246-2017-00514
• Device Sequence Number: 1212050
• Product Code: LXH
• UDI-Device Identifier: 00888867051843
• UDI-Public: 00888867051843
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 01/10/2018

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-8941KT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/10/2018
• 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
• Patient Age: 19 YR
• Patient Weight: 88