MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; SMOOTH FIXATION PIN

Model Number	TIGHTROPE ABS, 14 MM BUTTON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	12/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
It was reported that after a successfully surgery on (b)(6) 2022 the abs button snapped in half a few weeks after the initial surgery.A revision surgery was performed prior to the (b)(6) 2022.No further information received.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h6: health effect - clinical code, component, type of investigation, investigation findings, investigation conclusions, and h10, and updated information in g1.Additional information: since the device was not received, an evaluation of the product could not be performed and the reported event cannot be verified.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• Common Device Name: SMOOTH FIXATION PIN
• 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: 17198708
• Report Number: 1220246-2023-06979
• Device Sequence Number: 12462028
• Product Code: HTY
• UDI-Device Identifier: 00888867019638
• UDI-Public: 00888867019638
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE ABS, 14 MM BUTTON
• Device Catalogue Number: AR-1588TB-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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