MAUDE Adverse Event Report: ARTHREX INC. FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	AR-3603-2
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/12/2018
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.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
The sales rep reported that the small two pronged tip on the fibertak tigertail broke off when inserting the anchor into the drilled hole.The broken tip remains in the drill hole after anchor implantation.The surgeon and staff decided not to remove the broken fragment from the patient.The rep reported that the quality of the bone was hard.Follow-up investigation: the incident occurred during a medial collateral ligament repair.An x-ray was not taken to locate the un-retrieved fragment.The surgeon believes that the broken tip will stay in the drill hole underneath the anchor and will not cause any issue or problem for the patient.The case was completed successfully using the same device and without interruption.The rep stated they are pending confirmation from the customer if the device will be returned for evaluation.It has been confirmed that the small two pronged tip that remained in the patient is the tip of the fiber tak inserter device and not a part of the fibertak anchor itself.Additional information received 5/7/18 via facility medwatch report 220101-0000-2018-8013: patient age was (b)(6).Patient is not hispanic/latino.

• Brand Name: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7540114
• Report Number: 1220246-2018-00189
• Device Sequence Number: 2412642
• Product Code: MBI
• UDI-Device Identifier: 00888867231320
• UDI-Public: 00888867231320
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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 Expiration Date: 02/01/2021
• Device Catalogue Number: AR-3603-2
• Device Lot Number: 10034100
• 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: 04/30/2018
• Initial Report FDA Received Date: 05/24/2018
• 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
• Patient Age: 52 YR