MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MICRO CORKSCREW FT; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/03/2023
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
On (b)(6) 2023, it was reported by an arthrex employee via email that an ar-1318ft corkscrew ft broke during insertion.The broken fragments could not be retrieved.The case was completed using another ar-1319ft mini corkscrew ft in a new bone socket.This was discovered during a procedure.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-1318ft serial/batch number 14754785 was received for investigation.Functional testing not performed due that the device's tip was bent before received for investigation.No anchor or needles were returned.Visual evaluation found that the micro corkscrew driver tip was bent at the tip.No broken parts were identified on returned device.The root cause of the reported failure mode is undetermined.However, this event is most likely caused by prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• 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: 16618091
• Report Number: 1220246-2023-06492
• Device Sequence Number: 17665728
• Product Code: HWC
• UDI-Device Identifier: 00888867008519
• UDI-Public: 00888867008519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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 Model Number: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT
• Device Lot Number: 15003934
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown