MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff surgery the device broke inside the patient.The broken piece wasn`t retrieved from the patient.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.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-1927bcf-3-1 inserter was received for investigation.Visual inspection identified heavy suture breakage at the distal tip of the inserter.No damage was identified to the inserter itself.The method used to prepare the bone, as well as the bone quality encountered, were not provided.As the implant remains in the patient, no assessment could be made as to the condition of the implant.The cause remains undetermined.

• Brand Name: SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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: 12737955
• MDR Text Key: 283955476
• Report Number: 1220246-2021-03870
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867096790
• UDI-Public: 00888867096790
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

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: SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW
• Device Catalogue Number: AR-1927BCF-3-1
• Device Lot Number: 13015328
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1