MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1

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

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 06/17/2021

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

It was reported during an acl reconstruction with an internal brace the anchor broke on insertion.The implant was retrieved but the eyelet was not.It was replaced with a peek swivel lock ar-2324pslc and the very same event occurred.Once again the implant was retrieved but the eyelet remained in the patient.Another swivel lock was used and the case was continued and completed with no further issues.The patient is fine to date but the two eyelets still remain in the patient.

• Brand Name: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, 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: 12124174
• MDR Text Key: 262548910
• Report Number: 1220246-2021-03362
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867331310
• UDI-Public: 00888867331310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151342
• 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: 07/06/2021

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: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Device Catalogue Number: AR-1593-BC
• Device Lot Number: 12982084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/06/2021
• Date Device Manufactured: 03/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1