MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS, ALLOGRAFT GRAFTLINK CP; PIN, FIXATION, SMOOTH

Model Number	IMPL SYS, ALLOGRAFT GRAFTLINK CP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-1588al-cp allograft graftlink was being tightened down to the tibia with a spare btb tightrope, the sutures broke just below the button construct.The graft was pulled out and a new one was opened.Surgeon had to slightly alter procedure with a full tibial tunnel through the cortex and a 14mm button applied using an abs tightrope.This was discovered during an all inside allograft graftlink acl procedure.
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 confirmed.Visual evaluation identified that the sutures had torn.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: IMPL SYS, ALLOGRAFT GRAFTLINK CP
• Common Device Name: PIN, FIXATION, SMOOTH
• 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: 13619981
• Report Number: 1220246-2022-04506
• Device Sequence Number: 19363516
• Product Code: HTY
• UDI-Device Identifier: 00888867200654
• UDI-Public: 00888867200654
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/01/2022

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: IMPL SYS, ALLOGRAFT GRAFTLINK CP
• Device Catalogue Number: AR-1588AL-CP
• Device Lot Number: 14820933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/01/2022
• Date Device Manufactured: 12/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown