MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2021

Event Type  malfunction  

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2021, it was reported by a facility representative via phone that an ar-1922bc bio-composite pushlock suture anchor, broke in half during insertion.This was discovered during use in a shoulder arthroscopy on (b)(6) 2021.The surgeon, was able to remove a piece of the broken anchor however, the piece of the anchor that has the suture attached, remains secured in the patient.

• Brand Name: SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12616661
• MDR Text Key: 278117300
• Report Number: 1220246-2021-03786
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867022874
• UDI-Public: 00888867022874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/12/2021

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: SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
• Device Catalogue Number: AR-1922BC
• Device Lot Number: 12220354
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/12/2021
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1