MAUDE Adverse Event Report: ARTHREX, INC. CT SCREW DOUBLE LEAD LOCK, Ø3.5MM X 30MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	CT SCREW DOUBLE LEAD LOCK, Ø3.5MM X 30MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/29/2024, it was reported by a sales representative via email that a 3024-01 11-hole left alpha plate broke postoperatively through the oblong hole in the first bend of the plate.On (b)(6) 2024, the patient was implanted with the plate, and revision surgery is still to be determined.Per the sales representative, the patient did not report any falls or injuries.No additional information has been reported.Additional information received on 11/13/2024: during the initial surgery on (b)(6) 2024, a 3024-011 11-hole left alpha plate, two 8110-026 cortical bone screw, an 8110-028 cortical bone screw, three 8110-030 cortical bone screws, an 8114-024 double lead lock cortical screw, an 8114-026 double lead lock cortical screw, an 8114-028 double lead lock cortical screw, an 8114-030 double lead lock cortical screw, an 8124-028 fully threaded cancellous locking screw, an 8124-032 cancellous locking screw, fully threaded, an 8124-038 fully threaded cancellous locking screw, an 8124-040 fully threaded cancellous locking screw, an 8124-046 fully threaded cancellous locking screw, an 8124-048 fully threaded cancellous locking screw, an 8124-050 fully threaded cancellous locking screw, an ar-8935cl-18 kreulock compression screw, and an abs-2010-10 allosync pure were implant.An abs-10062t angel cprp system with aspiration kit was also used during the procedure.On (b)(6) 2024, it was discovered that the plate had broken.The patient underwent revision surgery on (b)(6) 2024.All the hardware from the original surgery on (b)(6) 2024 was removed and replaced with products from another manufaturer, a 10cc of arthrex allosync pure dbm, 5cc of arthrex arthrocell plus, and bone marrow aspirate from the iliac crest.
Additional Manufacturer Narrative
One unpackaged 8114-030 ct screw double lead lock, ø3.5mm x 30mm, serial/batch number: (b)(6), was received for evaluation.Visual inspection revealed damage to the screw threads near the head.Evaluation of the screw¿s hex head showed scratches and damage to the hex geometry.The observed damage on the screw is most likely due to it being implanted and then removed.Functional testing was conducted by screwing the returned screw into the returned 3024-011 alpha plate, left, 11-hole, serial/batch number: (b)(6).It was noted that the screw sat flush in the hole without issues.No problem was found.Arthrex concluded that there are no allegations against the 8114-030 ct screw double lead lock, ø3.5mm x 30mm, serial/batch number (b)(6).No related problem was found.

• Brand Name: CT SCREW DOUBLE LEAD LOCK, Ø3.5MM X 30MM
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• 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: 20915422
• Report Number: 1220246-2024-08810
• Device Sequence Number: 20982388
• Product Code: KTW
• UDI-Device Identifier: 00848665033434
• UDI-Public: (01)00848665033434(11)220505(10)213027
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CT SCREW DOUBLE LEAD LOCK, Ø3.5MM X 30MM
• Device Catalogue Number: 8114-030
• Device Lot Number: 213027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown