MAUDE Adverse Event Report: ARTHREX, INC. TIGERTAPE CERCLAGE W/O NEEDLE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	TIGERTAPE CERCLAGE W/O NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/03/2024
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 3024-016 16-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 on (b)(6) 2024, the plate was removed.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: the correct original surgery date is (b)(6) 2024.The patient was implanted with the 3024-016 16-hole left alpha plate, an 8110-026 cortical bone screw, two 8110-028 cortical bone screws, four 8114-026 double lead lock cortical screw, an 8114-036 double lead lock cortical screw, an 8124-030 fully threaded cancellous locking screw, an 8124-032 fully threaded cancellous locking screw, two 8124-036 fully threaded cancellous locking screw, two 8124-040 fully threaded cancellous locking screw, an 8124-042 fully threaded cancellous locking screw, two ar-7268t tigertape cerclage with fiberlink shuttle suture, and an abs-2010-10 allosync pure.During the revision surgery, all the hardware was removed.The revision surgery was completed using a 3012-014 proximal humeral plate, 14-hole, with additional screws.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint could not be confirmed based on the x-ray images provided from the field, as the ar-7268t device does not appear in the submitted images.Therefore, arthrex concluded that the reported failure was most likely due to a patient-specific event.

• Brand Name: TIGERTAPE CERCLAGE W/O NEEDLE
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 20790660
• Report Number: 1220246-2024-08641
• Device Sequence Number: 12715067
• Product Code: GAT
• UDI-Device Identifier: 00888867369900
• UDI-Public: (01)00888867369900(11)231004(17)280930(10)15149865
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232755
• 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): 08/21/2025

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: TIGERTAPE CERCLAGE W/O NEEDLE
• Device Catalogue Number: AR-7268T
• Device Lot Number: 15149865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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