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

Model Number	SUTURE ANCHOR, BIO-CORKSCREW FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
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 rotator cuff suture surgery, the anchor broke off.The broken piece was retrieved from the patient.There was no harm to the patient, operator, or third party reported.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 is confirmed.Upon visual evaluation, it was noted that the corkscrew was broken.No issues were noted with the driver or sutures.The method used to prepare the bone and the bone quality encountered during the procedure was not provided.The most likely cause can be attributed to improper bone preparation or prying/leveraging the screw during insertion.Functional testing was not performed due to the damage to the device.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• Common Device Name: 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: 16485070
• Report Number: 1220246-2023-06383
• Device Sequence Number: 12473712
• Product Code: MAI
• UDI-Device Identifier: 00888867096783
• UDI-Public: 00888867096783
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 08/31/2026
• Device Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF-1
• Device Lot Number: 15005343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown