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

Model Number	SUTURE ANCHOR, CORKSCREW FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a foot surgery it was found that the threads of the anchor were very thin in the middle and then tore apart at this point.There was no harm for 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
The complaint cannot be confirmed.One sealed, packaged ar-1915ft-1, batch 11622306 was received for investigation.The device involved in the event description was not returned for inspection.No problem was identified with the new, returned device once it was unpackaged.As such, the allegation cannot be confirmed.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT
• 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: 18643285
• Report Number: 1220246-2024-00776
• Device Sequence Number: 8240970
• Product Code: HWC
• UDI-Device Identifier: 00888867022614
• UDI-Public: 00888867022614
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• 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
• Report Date (Section B): 02/05/2024

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: 08/31/2025
• Device Model Number: SUTURE ANCHOR, CORKSCREW FT
• Device Catalogue Number: AR-1915FT-1
• Device Lot Number: 11622306
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2020
• 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