MAUDE Adverse Event Report: ARTHREX INC. DRIVER,3.5MM HEX,CANNULATED (MINI HUDSON); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-8967D
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/19/2017
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.Device history record review revealed nothing relevant to this event.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.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an arthroscopic ankle fusion/right ankle procedure, the tip of the 3.5mm hex driver broke off while the surgeon was driving the screw.The surgeon was able to remove the majority of the fragments, however, a small piece of the driver tip remained in the patient.A second driver from the tray was used to finish implanting screw successfully.Follow-up investigation: an x-ray was taken and confirm the presence of the fragment in the patient's posterior lateral ankle, however, the x-ray is not available.

• Brand Name: DRIVER,3.5MM HEX,CANNULATED (MINI HUDSON)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7178416
• Report Number: 1220246-2017-00509
• Device Sequence Number: 1212703
• Product Code: LXH
• UDI-Device Identifier: 00888867056718
• UDI-Public: 00888867056718
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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-8967D
• Device Lot Number: 47321731
• 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: 12/20/2017
• 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