MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL TENODESIS BUTTON REV: 0; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	PROXIMAL TENODESIS BUTTON REV: 0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a proximal biceps tendon refixation surgery the button couldn`t be detached (rotated) from the inserter.The thread is broken off on both items.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update avoe (b)(6) 2023: it was confirmed that the devices broke inside the patient and all fragments could be retrieved from the patient.Update avoe (b)(6) 2023: it was confirmed that the surgery was finished successfully with a different devices with the same part number.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.The complaint was confirmed.One unpackaged ar-2291 proximal tenodesis button batch 15042980 was received for evaluation.Upon visual inspection, it was found that the returned without the 9mm proximal biceps button attached to the threaded shaft.Evaluation of the threaded shaft found that the device is missing part of the threaded tip.The threaded shaft length measurement by drawing c12774 at revision 7 found the device's failed length specifications.It was observed that there were nicks on the cannulated shaft tip.The most likely cause(s) for the reported failure is prying/leveraging the device against bone or another instrument.

• Brand Name: PROXIMAL TENODESIS BUTTON REV: 0
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 17266721
• Report Number: 1220246-2023-07048
• Device Sequence Number: 18120619
• Product Code: MBI
• UDI-Device Identifier: 00888867026704
• UDI-Public: 00888867026704
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123341
• 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): 03/11/2024

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: PROXIMAL TENODESIS BUTTON REV: 0
• Device Catalogue Number: AR-2291
• Device Lot Number: 15042980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown