MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MINI BC PUSHLOCK; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, MINI BC PUSHLOCK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by an arthrex employee via email that an (4) ar-8825bc biocomposite pushlock were being used in a procedure.Two of the four broke when threading the tapes through the eyelet and another had the screw break when it was being inserter in the bone hole.
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 not confirmed.Upon visual inspection, no problems were noted with the devices.Only inserters for the devices were received.

• Brand Name: SUTURE ANCHOR, MINI BC PUSHLOCK
• Common Device Name: SCREW, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15657363
• Report Number: 1220246-2022-05646
• Device Sequence Number: 20429912
• Product Code: HWC
• UDI-Device Identifier: 00888867247901
• UDI-Public: 00888867247901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063479
• 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): 01/03/2023

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: 04/30/2024
• Device Model Number: SUTURE ANCHOR, MINI BC PUSHLOCK
• Device Catalogue Number: AR-8825BC
• Device Lot Number: 14956900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown