MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK SP, 5.5X24.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMP SWIVELOCK SP, 5.5X24.5MM

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2023

Event Type  malfunction  

Event Description

It was reported that during a surgery the anchor couldn`t be fixed, it was rotating.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

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.

• Brand Name: BIO-COMP SWIVELOCK SP, 5.5X24.5MM
• Type of Device: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17976722
• MDR Text Key: 326308369
• Report Number: 1220246-2023-08280
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867097926
• UDI-Public: 00888867097926
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K151342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIO-COMP SWIVELOCK SP, 5.5X24.5MM
• Device Catalogue Number: AR-2323BCM-1
• Device Lot Number: 15097478
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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