MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/21/2022, it was reported by an arthrex employee via email that an ar-1662bc biocomposite swivelock inserter could not be pulled out and when surgeon was able to, the anchor pulled out of implantation site as well.Surgeon drilled an additional bone hole and used a new ar-1662bc biocomposite swivelock to complete the case.This was discovered during a rcr procedure on 2/18/2022.No further issues has been reported.
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.The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.

• Brand Name: SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19163817
• Report Number: 1220246-2024-02242
• Device Sequence Number: 7382231
• Product Code: MAI
• UDI-Device Identifier: 00888867020566
• UDI-Public: 00888867020566
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101823
• 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): 04/23/2024

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: 09/30/2024
• Device Model Number: SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
• Device Catalogue Number: AR-1662BC
• Device Lot Number: 11977022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown