MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DX SUTURE ANCHOR WITH 1.33MM SUTURE TAPE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number AR-8990ST

Device Problems Break (1069); Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/24/2021

Event Type  malfunction  

Event Description

Suture anchor failed to properly deploy correctly resulting in a piece of the tip of the shaft of the inserter to become imbedded in bone.This anchor was never implanted into the patient, the tip was not removed.Fda safety report id# (b)(4).

• Brand Name: FIBERTAK DX SUTURE ANCHOR WITH 1.33MM SUTURE TAPE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 12092549
• MDR Text Key: 259387906
• Report Number: MW5102206
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867301054
• UDI-Public: (01)00888867301054
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-8990ST
• Device Catalogue Number: AR-8990ST
• Device Lot Number: 12328030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 57