MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MINI BIO-PUSHLOCK; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, MINI BIO-PUSHLOCK
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/02/2024, it was reported by an arthrex subsidiary employee via email that an ar-8825b suture anchor would not seperate from the screw once inserted.The case was completed using another ar-8825b with unknown lot numbers.
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
Complaint allegation is confirmed.-visual inspection identified the screw of the suture anchor, mini bio-pushlock¿ 2.5 mm x 8 mm had come loose on the shaft.Functional testing was not performed; the screw was separate and loose on the shaft.The quality of the bone encountered was not provided.The most likely cause for the reported failure can be attributed misuse/mishandling due to damage to the device.

• Brand Name: SUTURE ANCHOR, MINI BIO-PUSHLOCK
• 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: emily shafer ; 8009337001
• MDR Report Key: 18581148
• Report Number: 1220246-2024-00537
• Device Sequence Number: 7139477
• Product Code: MAI
• UDI-Device Identifier: 00888867046641
• UDI-Public: 00888867046641
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173240
• 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): 08/05/2024

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: 01/31/2026
• Device Model Number: SUTURE ANCHOR, MINI BIO-PUSHLOCK
• Device Catalogue Number: AR-8825B
• Device Lot Number: 14921518
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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