MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM BC CORKSCREW FT W/ SUTURETAPE; BIO SOFT TISSUE FIXATN FASTNR

Model Number 5.5MM BC CORKSCREW FT W/ SUTURETAPE

Device Problem Break (1069)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that during a shoulder arthroscopy the anchor twisted off immediately and broke despite punching and thread cutting.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.Update avoe 26-mar-2024 it was confirmed that all fragments were retrieved from the patient.

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: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• 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: jared engle ; 8009337001
• MDR Report Key: 19051428
• MDR Text Key: 339492270
• Report Number: 1220246-2024-01827
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867251267
• UDI-Public: 00888867251267
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082810
• 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: 04/05/2024

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: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Device Catalogue Number: AR-1927BCT
• Device Lot Number: 15133276
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2023
• 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