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

Model Number	FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a bankart repair procedure the glenoid was prepped with a 1.9 mm flex drill and upon insertion of the double loaded fibertak with #2 tigertail, there was lag and when the surgeon went to pull back on the drill guide, it became noticed that the inserter had broken.The inserter tip is lodged into the anchor itself and remained in the patient.The fragment was deep enough that the surgeon was unable to see it or reach it with a probe.He then tied the suture and labrum down over it.

• 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: 7800664
• Report Number: 1220246-2018-00603
• Device Sequence Number: 19118493
• Product Code: MBI
• UDI-Device Identifier: 00888867231320
• UDI-Public: 00888867231320
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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 Expiration Date: 10/31/2021
• Device Model Number: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• Device Catalogue Number: AR-3603-2
• Device Lot Number: 10074161
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/21/2018
• 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