MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK; SCREW, FIXATION, BONE

Model Number SUTR ANCH,BIO-COMP S-TAK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/20/2020

Event Type  Injury  

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

It was reported that after a bankart repair surgery during a post-op follow up scans and imaging revealed severe cyst formation around the implanted device, including chondrolysis.No piece of the device broke off during the initial surgery.A second surgery has to be performed.

• Brand Name: SUTR ANCH,BIO-COMP S-TAK
• Type of Device: SCREW, FIXATION, BONE
• 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: 11761268
• MDR Text Key: 248620698
• Report Number: 1220246-2021-02992
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867023888
• UDI-Public: 00888867023888
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K140855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: SUTR ANCH,BIO-COMP S-TAK
• Device Catalogue Number: AR-1934BCF-2
• Device Lot Number: 10300098
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Date Device Manufactured: 04/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other