MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK SUTURE ANCHOR; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERTAK SUTURE ANCHOR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2019
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 the arthrex fibertak ar-3600-1 was used for a shoulder stabilization.The tip of the device broke off inside the anchor.The anchor was still correctly inserted and fixed.The surgeon thought he had completely removed the broken tip.After the surgery it was found that the tip broke into two parts and only one part of it was removed.For this reason the patient had to be re-surgeried one day later on the (b)(6) 2019.The second part of the broken off tip was successfully removed with the help of the radiograph.Nothing remains in the patient.
Additional Manufacturer Narrative
Complaint confirmed, the tip of the device broke off, and one leg of the device tip broke off.The most likely causes include prying and/or leveraging the device during use.

• Brand Name: FIBERTAK SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9376476
• Report Number: 1220246-2019-01440
• Device Sequence Number: 16904128
• Product Code: MBI
• UDI-Device Identifier: 00888867284814
• UDI-Public: 00888867284814
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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 Model Number: FIBERTAK SUTURE ANCHOR
• Device Catalogue Number: AR-3600-1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/05/2019
• Patient Sequence Number: 1