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

Model Number	SUTURE ANCHOR, CORKSCREW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a rotator cuff repair surgery when pulling back the guide sleeve of the anchor, parts of the sleeve and the anchor broke off.All metal parts that broke off could be removed and the anchor remains functional in the bone.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Upon visual inspection, it was noted that the corkscrew and sutures of the suture anchor, corkscrew® 5 mm x 15.5 mm with #2 fiberwire® and #2 tiger wire® were not returned.The hex's edges at the distal end of the shaft were chipped.However, the corkscrew was not returned for investigation.Functional testing was not performed due to the missing corkscrew.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTURE ANCHOR, CORKSCREW
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 20353424
• Report Number: 1220246-2024-07938
• Device Sequence Number: 6517632
• Product Code: HWC
• UDI-Device Identifier: 00888867022829
• UDI-Public: (01)00888867022829(11)240206(17)290131(10)15203467
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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, CORKSCREW
• Device Catalogue Number: AR-1920SF
• Device Lot Number: 15203467
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown