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

Catalog Number	AR-8941KT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/26/2018
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.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 whilst implanting a cannulated screw, the tip of approximately 5 mm from a 1.6 mm k wire broke-off in the patient's bone.The surgeon assessed the situation and decided that it would be in the patient's best interest to leave the tip in the bone as it would cause more damage to remove the fragment.Performed surgery was a triple ankle fusion.The surgery was completed with the same device anyway.
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.Complaint confirmed.One of the two guide wires was received with the trocar tip missing.During testing, the device passed material specification.Complainant's event typically caused by prying/leveraging during use.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 whilst implanting a cannulated screw, the tip of approximately 5mm from a 1.6mm k wire broke-off in the patient's bone.The surgeon assessed the situation and decided that it would be in the patient's best interest to leave the tip in the bone as it would cause more damage to remove the fragment.Performed surgery was a triple ankle fusion.The surgery was completed with the same device anyway.

• 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: 7439309
• Report Number: 1220246-2018-00147
• Device Sequence Number: 11020521
• Product Code: LXH
• UDI-Device Identifier: 00888867051843
• UDI-Public: 00888867051843
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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