MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP. INTERFERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1380TC
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device will not be returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.This is the first complaint of this type for this part/lot combination.The potential causes of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.
Event or Problem Description
It was reported that a few weeks after a (b)(6) 2015 acl procedure the patient claimed about the appearance of a bulge close to the knee (subcutaneus).The screw was removed in the middle of september 2016 (specific revision date not provided.(b)(6) 2016 will be used as the event date).Ligament fixation is stable.Patient male, (b)(6).

• Brand Name: BIO-COMP. INTERFERENCE SCREW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6037754
• Report Number: 1220246-2016-00424
• Device Sequence Number: 19073034
• Product Code: MAI
• UDI-Device Identifier: 00888867015357
• UDI-Public: 00888867015357
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2016

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 Expiration Date: 06/17/2015
• Device Catalogue Number: AR-1380TC
• Device Lot Number: 1247310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2016
• Initial Report FDA Received Date: 10/18/2016
• 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
• Patient Age: 25 YR