MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 10MM; POLYETHYLENE SYNTHETIC SUTURE

Model Number	QUADLINK IMPLANT SYSTEM, 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/13/2023, it was reported by a sales representative via email that the flipcutter iii from an ar-1288qis-100 quadlink implant system broke while retro drilling the tibial tunnel.The flipcutter iii did not complete the bone socket and closed back to a 3.5mm in diameter.The surgeon opened a new ar-1204ff flipcutter iii to continue drilling, and this one wobbled while on power, after attempting to chuck it multiple times.This was discovered during an all-inside aclr procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1288qis-100 was received for investigation.Visual evaluation found that the flipcutter drill guide was broken off.The most likely cause for the reported failure is a user error.Per ref-02463.Warnings.Do not use excessive tension or overload the device, as either could lead to device pullout or damage/breakage.

• Brand Name: QUADLINK IMPLANT SYSTEM, 10MM
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 17287522
• Report Number: 1220246-2023-07100
• Device Sequence Number: 5523455
• Product Code: GAT
• UDI-Device Identifier: 00888867344754
• UDI-Public: 00888867344754
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112990
• 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): 10/31/2024

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: QUADLINK IMPLANT SYSTEM, 10MM
• Device Catalogue Number: AR-1288QIS-100
• Device Lot Number: 15098002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2023
• 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