MAUDE Adverse Event Report: ARTHREX, INC. NIT G-PIN. BIO-INTERFERENCE SCREW 1.1MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-1249
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/07/2016
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.The device was requested/is expected for evaluation but has not yet been received.The contribution of the device to the event as reported could not be determined as the device was not returned for evaluation.Lot number was not provided so device history record review cannot be performed.This type of event is typically caused by excessive driver force applied over the guide pin, driver tip hitting a flex point of the guide pin, prying/leveraging on the guide during use and/or re-using a guide pin from the single-use disposable kit that has been bent from prior use.The potential cause(s) of this event will be 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 after the acl surgery, during the control x-ray, the surgeon found a fragment of the pin.He did a second surgery the same day to remove it.No more information has been made available by the customer.

• Brand Name: NIT G-PIN. BIO-INTERFERENCE SCREW 1.1MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6180339
• Report Number: 1220246-2016-00588
• Device Sequence Number: 16323444
• Product Code: MDM
• UDI-Device Identifier: 00888867006164
• UDI-Public: 00888867006164
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/16/2016

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-1249
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 12/16/2016
• 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