MAUDE Adverse Event Report: ARTHREX, INC. SCREWDRIVER, CANNULATED PINLOCK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-1896
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Several attempts have been made to gather additional information from the reporter of medwatch (b)(4).To date no response has been received.Based on the information provided in the medwatch report, with no further information obtained, arthrex is unable to confirm if the device tip was retrieved from the patient.No further patient information was obtained regarding 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 requested but no response was received and it's disposition is unknown.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.The typical cause(s) of this type of event include flexing the joint during insertion of the implant with the driver engaged or prying/leveraging the driver while the implant is still loaded.Lot number was not provided so device history record review cannot be performed.
Event or Problem Description
It was reported via a facility medwatch ((b)(4)) that on (b)(6) 2016 during an acl reconstruction procedure, the surgeon was using the ar-1896 screwdriver to place a screw and the tip of the screwdriver broke-off in the head of the screw.Several attempts have been made to gather additional information from the reporter of medwatch (b)(4).To date no response has been received.

• Brand Name: SCREWDRIVER, CANNULATED PINLOCK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5943432
• Report Number: 1220246-2016-00392
• Device Sequence Number: 1581961
• Product Code: LXH
• UDI-Device Identifier: 00888867022423
• UDI-Public: 00888867022423
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2016

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-1896
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2016
• 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