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

Model Number	SUTURE ANCHOR BIOCOMPOSI CORKSCREW FT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2021
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 that during a shoulder arthroscopy the devices broke inside the patient and the broken parts remained inside the patient.As the device is absorbable no revision surgery is planned.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.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1927bcf-65-1 was received for investigation.Visual inspection identified breakage to the distal threads of the returned biocomposite anchor.The associated suture construct remained intact.Details as to the method of bone preparation employed during the procedure, as well as the bone quality encountered, were not provided.As such, a probable cause can be associated with improper bone preparation and/or user applied prying/leveraging forces during insertion.

• Brand Name: SUTURE ANCHOR BIOCOMPOSI CORKSCREW FT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12198234
• Report Number: 1220246-2021-03412
• Device Sequence Number: 5244764
• Product Code: MAI
• UDI-Device Identifier: 00888867096820
• UDI-Public: 00888867096820
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 06/30/2024
• Device Model Number: SUTURE ANCHOR BIOCOMPOSI CORKSCREW FT
• Device Catalogue Number: AR-1927BCF-65-1
• Device Lot Number: 11345202
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1