MAUDE Adverse Event Report: ARTHREX, INC. SCRW,CANN. INT.,FULL THD; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SCRW,CANN. INT.,FULL THD
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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
On 08/09/2024, an arthrex subsidiary employee reported via sems-(b)(4) that an ar-1400t full thread cannulated interference screw, when inserted in the tibial tunnel, lost the thread and came off the screw material and began to tear the graft (see photo attachment).Another implant was used instead to complete the case.This occurred during an lca procedure on (b)(6) 2024, additional information was received on 09/02/2024: the ar-1400t full thread cannulated interference screw was completely removed from the patient.There was no case delay reported and no additional anesthesia administered.Another r-1400t full thread cannulated interference screw from a different lot was used to complete the case.No adverse effects on the patient were reported.
Event or Problem Description
Additional information was received on 11/04/2024: the correct screw part number for this complaint allegation is ar-1400tc biocomposite interference screw, full thread, 10 mm x 28 mm / lot: 15076439.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Complaint allegation is confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SCRW,CANN. INT.,FULL THD
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 20136908
• Report Number: 1220246-2024-07354
• Device Sequence Number: 7417455
• Product Code: MAI
• UDI-Device Identifier: 00888867016217
• UDI-Public: 00888867016217
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K062466
• 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): 12/04/2024

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 Model Number: SCRW,CANN. INT.,FULL THD
• Device Catalogue Number: AR-1400T
• Device Lot Number: 15076439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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