MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SUTURETAK; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PEEK SUTURETAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ar-1934ps implant was well placed.A bone hammer was used to hammer the end of the product gently to secure the implant into the bone socket.The ligament was sewn.The implant was out of the socket while the tying the suture into a knot.Finally, the procedure was successfully completed using a product of other manufacturer.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-1934ps suturetak was received for investigation.It was identified that the suturetak driver, as well as a 20.12" long suture fragment, were returned for inspection.However, the biocomposite anchor was not returned for analysis.Fraying was observed at one end of the suture, indicating breakage.No problem was found with the returned driver.The unfixed condition of the anchor was able to be confirmed through the customer provided photo.This event is most likely the result of suture breakage either from the application of excessive force or through nicking the suture against sharp bone or other instrumentation.As the anchor itself was not returned, further analysis cannot be conducted.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 19449317
• Report Number: 1220246-2024-04751
• Device Sequence Number: 3213724
• Product Code: HWC
• UDI-Device Identifier: 00888867024168
• UDI-Public: 00888867024168
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061863
• 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
• Report Date (Section B): 06/03/2024

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 Expiration Date: 04/30/2025
• Device Model Number: SUTURE ANCHOR, PEEK SUTURETAK
• Device Catalogue Number: AR-1934PS
• Device Lot Number: 11039165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2021
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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
• Patient Sex: Unknown