MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,ACL T-ROPE RT; PIN, FIXATION, SMOOTH

Model Number	IMPL DELIVERY SYS,ACL T-ROPE RT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
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 device remains in the patient.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient underwent a primary acl reconstruction with a semi allograft on (b)(6) 2019.The patient returned for post op follow up in the surgeon's office and x-rays found that the cortical rt button appeared to be within the femoral canal.Clinically the patient was felt to have a positive lachman, although they were not symptomatic.On (b)(6) 2019, the patient was brought back to the operating room; the tails of the tightrope were found through a lateral incision and fixed proximally with a 4.75 swivelock to re-tension the graft.A 3.5 swivelock was placed in the 4mm cortical exit hole and the tightrope and button were left in place.The surgeon was happy with graft tension and felt the lachman was now negative.Additional information provided 10/31/2019: there were no devices removed from the patient.

• Brand Name: IMPL DELIVERY SYS,ACL T-ROPE RT
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9261234
• Report Number: 1220246-2019-01387
• Device Sequence Number: 3731382
• Product Code: HTY
• UDI-Device Identifier: 00888867019607
• UDI-Public: 00888867019607
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K100652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: IMPL DELIVERY SYS,ACL T-ROPE RT
• Device Catalogue Number: AR-1588RTS
• Device Lot Number: 10335583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1