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

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

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 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
• Type of Device: 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: 9261234
• MDR Text Key: 173252315
• Report Number: 1220246-2019-01387
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019607
• UDI-Public: 00888867019607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1