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U.S. Department of Health and Human Services

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

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ARTHREX, INC. IMPL DELIVERY SYS,ACL T-ROPE RT; PIN, FIXATION, SMOOTH Back to Search Results
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.
 
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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 Key5165866
MDR Text Key28905319
Report Number1220246-2015-00279
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K100652
Number of Events Reported1
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 Date04/01/2020
Device Catalogue NumberAR-1588RTS
Device Lot Number1441927
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/29/2015
Initial Date FDA Received10/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age25 YR
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