MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/17/2020
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 not returned for evaluation.The root 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 posterior labrum refixation, the tip of the device broke off which causes that the suture could not move freely anymore.The fragment could not be retrieved.The two sutures had to be cut off and knotted together.One suture was well fixed to stay in place upon tension.The surgery was successfully finished by rethreading the labrum with a fw 2 and knotting to the fixed suture from the anchor.Update 20-feb-2020: bone quality was good, bone prep.As usual, drilling through a cannula, delay of surgery about 30 min.

• Brand Name: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9806219
• Report Number: 1220246-2020-01751
• Device Sequence Number: 3003210
• Product Code: MBI
• UDI-Device Identifier: 00888867206953
• UDI-Public: 00888867206953
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K151230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: 08/31/2024
• Device Model Number: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• Device Catalogue Number: AR-3602-2
• Device Lot Number: 10378361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other