MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT W/ DEPLOYING SUTURE; PIN, FIXATION, SMOOTH

Model Number ACL TIGHTROPE RT W/ DEPLOYING SUTURE

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Fluid Discharge (2686)

Event Date 04/26/2019

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 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 an acl reconstruction procedure on (b)(6) 2019 where the following devices were implanted: ar-1588rt-j lot: 10259067.Ar-1897s lot: 10224925.Ar-4030c-10 lot: 10198681.Ar-7209t lot: 12863.Jrf speedgraft id: (b)(4) (not an arthrex product).This case was completed with no issue.The patient was seen for his first post-op visit on (b)(6) 2019 and per the pa: ¿skin intact; port and graft incisions clean, dry and intact with sutures.No erythema or signs of infection.Mild redness secondary to suture reaction.¿ the patient was seen for a 2nd follow-up visit and the surgeon reported: ¿35ml of serosanguinous fluid aspirated from the right knee after alcohol prep, no hint of turbclity.¿ this was done in response to increased dwelling and disability for three days.Surgeon reports: ¿not clinically a dvt; infection a concern, but also, clinically, does not look like it.¿ patient was placed on bactrimds by mouth twice daily for seven days.The fluid was sent for cell count.Per the report, the fluid was cloudy with total nucleated cell count at 6800 and neutrophils at 75.The patient was seen for his third post-op follow up visit on (b)(6) 2019.The patient was still having right knee effusions with limited rom and pain.The following was reported: ¿no redness or drainage but there is an effusion and 25cc of slightly turbid yellow fluid aspirated.¿ aspirate fluid sent for cell count and per the report, the fluid was cloudy with total nucleated cell count at 31800 and neutrophils at 85.The surgeon ordered the patient to continue bactrim.On (b)(6) 2019, the patient underwent an arthroscopic washout and a limited synovectomy to the right knee for possible post-op septic.The patient received 2g iv antibiotics and was washed out with triple antibiotic irrigation.On (b)(6) 2019 the surgeon stated that the patient¿s c-reactive protein is double normal indicating a non-specific inflammation.The rep spoke with the surgeon on 5/9 and he stated that the patient has completed a 2 week course of iv antibiotics and that he is treating the patient as if he has an infection but the cultures have come back negative.As of (b)(6) 2019, the cell count for the aspirate fluid is 2000.The surgeon stated that the patient is possible having a reaction to the graft.Rep requested follow-up visit reports from (b)(6) 2019 to (b)(6) 2019 and upon receipt of reports, the patient had a follow-up visit where he underwent a s/p surgery on (b)(6) 2019.The patient is on iv antibiotics at home.The surgeon indicates that the culture done during the (b)(6) 2019 follow-up showed no growth.Surgeon states in his follow up notes: ¿the dx of infection after his acl reconstruction is not a certainty but something is severely irritating his knee and we are erring on the side of caution.The plan is 3 weeks of iv vanco and cipro with weekly lab tests.¿ additional information provided (b)(6) 2019: the op notes and md office are unaware if the original acl repair was done with arthrex products.Patient has previous bilateral acl reconstruction in 1994 and 1996.In between follow-ups, the patient was admitted to the hospital on (b)(6) 2019 and discharged (b)(6) 2019.Patient followed by home health for iv abx via picc line.Iv abx therapy completed (b)(6) 2019.As of last visit with the surgeon ((b)(6) 2019), the infection resolved.Per notes "resolved post op infection though we never grew any germs." the surgery was for a washout only.There were no arthrex products removed and there is no plan to have any arthrex products removed.

• Brand Name: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• 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: 8734851
• MDR Text Key: 149258610
• Report Number: 1220246-2019-01165
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867095533
• UDI-Public: 00888867095533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 10259067
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR