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

Model Number	SUTURE ANCHOR, MINI BC PUSHLOCK
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
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
On (b)(6) 2021, it was reported by a sales representative via sems that an ar-8825bc suture anchor cracked upon insertion.This was discovered during use in an unspecified procedure.The case was completed with a new ar-8825bc.
Additional Manufacturer Narrative
The complaint cannot be confirmed without the return of the device for evaluation.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.According to dfu-0087.Section e.Warnings.6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.Section g.Precautions.3.Make sure to use the recommended drill bit or punch to create the bone socket.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.6.Pushlock and swivelock suture anchors only: ensure that the anchor body is in full contact with the bone before advancing the anchor body into the prepared bone socket.

• 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: 12737947
• Report Number: 1220246-2021-03869
• Device Sequence Number: 17340466
• Product Code: HWC
• UDI-Device Identifier: 00888867247901
• UDI-Public: 00888867247901
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 05/31/2022
• Device Model Number: SUTURE ANCHOR, MINI BC PUSHLOCK
• Device Catalogue Number: AR-8825BC
• Device Lot Number: 11121579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown