MAUDE Adverse Event Report: ARTHREX, INC. FIBERLOCK SUSPENSION SYSTEM; BONE FIXATION SCREW/PLATE

Model Number	FIBERLOCK SUSPENSION SYSTEM
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/24/2023, it was reported by a sales representative via email that an ar-8988-cp fiberlock suspension system was missing the threaded drill guide.This was discovered during a procedure on (b)(6) 2023.Additional information received on 8/1/2023: this was discovered during a cmc arthroplasty suture anchor suspensionplasty.The case was completed using another ar-8988-cp fiberlock suspension system.
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
Correction, h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

• Brand Name: FIBERLOCK SUSPENSION SYSTEM
• 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: 17605652
• Report Number: 1220246-2023-07602
• Device Sequence Number: 6307987
• Product Code: MBI
• UDI-Device Identifier: 00888867377875
• UDI-Public: 00888867377875
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• 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): 10/07/2024

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 Model Number: FIBERLOCK SUSPENSION SYSTEM
• Device Catalogue Number: AR-8988-CP
• Device Lot Number: 15068482
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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