MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a shoulder arthroscopy the anchor broke off in two parts outside the joint.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, peek suture tak, ar-1938ps, serial/batch number (b)(6), was received for investigation.Functional testing was not performed due to the damage to the anchor of the device.Visual inspection noted that fragment of the sutures was returned for evaluation.Additionally, it was noted that the anchor was broken at the distal and proximal end.The most likely cause is attributed to misuse due to prying/leveraging the device during use.

• Brand Name: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• 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: jared engle ; 8009337001
• MDR Report Key: 19603825
• Report Number: 1220246-2024-06402
• Device Sequence Number: 7326655
• Product Code: MAI
• UDI-Device Identifier: 00888867024229
• UDI-Public: 00888867024229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Device Catalogue Number: AR-1938PS
• Device Lot Number: 15155348
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown