MAUDE Adverse Event Report: ARTHREX, INC.; NON-DEGRADABLE FIXATN FASTENER

Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, it was reported by a patient via phone that a cmc tightrope system had failed after additional surgery, the part and lot number were unknown.The patient had an initial basal arthroscopy and tendon transfer procedure in the left thumb on (b)(6), 2021.No arthrex products were used in the initial procedure due to her knowledge.The patient stated shortly after the procedure, it did not feel right.Mris were taken, and a dynamic study of the hand was made, and it was discovered that the tendon was gone, and there was a crunching noise heard.Upon seeing a different surgeon, it was confirmed that the tendon had detached afterward.On (b)(6) 2023, an additional surgery with the arthrex cmc tightrope was performed.On (b)(6), 2023, an x-ray was taken, and the tightrope buttons were there, but the bone was dropped.An mri will be scheduled soon to verify the location of the braided polyester.She asked about failure modes for this type of surgery and the cmc tightrope system and stated that this was not a complaint, but her body seemed to have rejected the device.She said she was not trying to sue or blame anyone, but she was worried that it might be her body, she also has arthritis and wanted to learn more about this device.This was resolved by suggesting verifying the product parts used in the additional surgery by her surgeon and then sending in the details of her inquiry via email to product surveillance for further information.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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 for the reported failure can be attributed to a patient-specific event.

• Brand Name: UNK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: emily shafer ; 8009337001
• MDR Report Key: 17626435
• Report Number: 1220246-2023-07648
• Device Sequence Number: 6136006
• Product Code: MBI
• UDI-Device Identifier: 00888867319707
• UDI-Public: 00888867319707
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 12/20/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown