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
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem 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
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12124174
• Report Number: 1220246-2021-03362
• Device Sequence Number: 13826312
• Product Code: MAI
• UDI-Device Identifier: 00888867331310
• UDI-Public: 00888867331310
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1