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

Catalog Number AR-1588RTS

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.This type of event is most likely caused by applying excessive force on the shortening strands, nicking the suture with another instrument, fraying from sharp edge of the bone tunnel.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.Device expected but not yet returned.

Event Description

It was reported by the surgeon that on final tensioning on the femoral side, the shortening strand snapped.Initial evaluation demonstrated stability.However post-op x-rays revealed a displaced femoral button.Graft and tunnel are good but button is floating.Procedure was an acl reconstruction with tightrope.Follow-up investigation: surgeon has provided the following: revision surgery was performed (b)(6) 2015.The loose femoral device was identified in the posterior recess of the knee capsule.Surgeon was unable to retrieve the foreign body arthroscopically.Eventually, the button was removed through an open exploration of the posterior knee via a lateral approach.The patient has residual hypesthesia throughout the posterior leg, but is otherwise neurovascularly intact.Surgeon attempted to salvage the index autograft by attaching another rt device to the femoral stump.After repeat graft fixation was complete, it was readily apparent that graft integrity was compromised.The entire autograft construct was removed including the index tibial rt device (lot 1441927/part ar-1588rts) and the secondary femoral device.Lastly, revision aclr was performed with an allograft secured by two rt devices.

• 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, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5165866
• MDR Text Key: 28905319
• Report Number: 1220246-2015-00279
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K100652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2015

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 Expiration Date: 04/01/2020
• Device Catalogue Number: AR-1588RTS
• Device Lot Number: 1441927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: 25 YR