MAUDE Adverse Event Report: ARTHREX INC. HD HIP ARTHROSCOPE, 70 DEG, 3.5X206MM

Catalog Number	AR-3350-4070H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2018
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.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.There is damage to the distal tip and the unit has a bent shaft.Typically a bent shaft is caused by prying/leveraging the device during use when it is not properly inserted into the guide sheath and/or mishandling.The directions for use (dfu-0073) states: inspect the medical instruments for damage prior to use and at all stages of handling thereafter.If damage is detected, do not use the medical instruments prior to consulting the manufacturer for guidance.Do not subject the medical instruments to impact.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 originally reported that the lens will not focus.Follow-up investigation: the case was stopped and the incision was closed.The patient was brought out of anesthesia.The rep went to another location and got another scope.The case was continued a few hours later and there were no issues.

• Brand Name: HD HIP ARTHROSCOPE, 70 DEG, 3.5X206MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7285134
• Report Number: 1220246-2018-00053
• Device Sequence Number: 19135172
• Product Code: HRX
• UDI-Device Identifier: 00888867029675
• UDI-Public: 00888867029675
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/21/2018

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-3350-4070H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/21/2018
• 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