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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX INC. TIGHTROPE ABS, IMPLANT, OPEN; PIN, FIXATION, SMOOTH

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ARTHREX INC. TIGHTROPE ABS, IMPLANT, OPEN; PIN, FIXATION, SMOOTH Back to Search Results
Catalog Number AR-1588TN-1
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Swelling (2091)
Event Date 01/06/2017
Event Type  Injury  
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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.This is one of four submissions from the same event.The others are (b)(4).Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
 
Event Description
It was reported by a patient that on (b)(6) 2017 she had a pcl reconstruction.During that procedure an arthrex dog bone button, was implanted.The patient has been experiencing an achy pain and swelling at and below the knee which began right after the procedure and has been ongoing.While recovering from the pcl procedure the patient suffered an injury and required a double meniscus transplant which took place on (b)(6) 2017.The achy pain and swelling continued after the (b)(6) 2017 procedure and still continues at time of this report.Patient notes that she is a runner and over the years has had a total of seven surgeries on this knee.No issues occurred after any of the surgeries that took place prior to the (b)(6) 2017 pcl procedure.It has only been since that procedure that she has had to deal with these types of problems.Patient also noted that she has had past auto immune issues in her life and would like to rule out any possibility of an allergic reaction to the arthrex implants.Patient will obtain the full part numbers of all implants from (b)(6) 2017 procedure as well as all (b)(6) 2017 procedure implants if any.Patient is requesting material composition of all arthrex part numbers once part numbers are provided.Follow-up investigation: implant logs from the (b)(6) 2017 and the (b)(6) 2017 procedures have been provided.During the (b)(6) 2017 procedure (left knee arthroscopy - past leg reconstruction) the following arthrex products were implanted: ar-1588btb, arthrex btb tightrope, lot 10055612; ar-1588tn-1, arthrex tightrope abs implant, lot 10066787; ar-2324bcc, arthrex suture anchor, biocomposite swivelock, lot 10065466; and ar-2270, arthrex dog bone button, lot 10066295.The (b)(6) 2017 procedure did not involve any arthrex implants.Patient female, (b)(6) at time of (b)(6) 2017 procedure.
 
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Brand Name
TIGHTROPE ABS, IMPLANT, OPEN
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, adverse events
1370 creekside boulevard
naples, FL 34108-1945
8009337013
MDR Report Key7600212
MDR Text Key111011215
Report Number1220246-2018-00219
Device Sequence Number1
Product Code HTY
UDI-Device Identifier00888867019713
UDI-Public00888867019713
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2018
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 Date09/01/2021
Device Catalogue NumberAR-1588TN-1
Device Lot Number10066787
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/21/2018
Initial Date FDA Received06/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2016
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 Age49 YR
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