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

Catalog Number	AR-1588TB-1
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/23/2016
Type of Reportable Event	Serious Injury
Additional 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.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.Device history record review revealed nothing relevant to this event.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 additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that a graftlink procedure was completed with a tighrope rt on the femur and an abs tightrope, ar-1588tb-1, on the tibia, secured with 14mm button distally.The knee was cycled and tensioned and retensioned.When the surgeon flexed the knee to remove the drapes, the abs button snapped in two across the line of the two holes.The surgeon had to reopen the incision (surgical intervention) and removed the broken button and tied the remaining sutures over another 14mm button.Case was acl revision.
Additional 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.This is a follow-up submission due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The device met all material specifications as received.The evaluation revealed the button has been split into two pieces.The cause of the event is undetermined.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 additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that a graftlink procedure was completed with a tighrope rt on the femur and an abs tightrope, ar-1588tb-1, on the tibia, secured with 14mm button distally.The knee was cycled and tensioned and retensioned.When the surgeon flexed the knee to remove the drapes, the abs button snapped in two across the line of the two holes.The surgeon had to reopen the incision (surgical intervention) and removed the broken button and tied the remaining sutures over another 14mm button.Case was acl revision.

• Brand Name: TIGHTROPE ABS BUTTON
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5791155
• Report Number: 1220246-2016-00291
• Device Sequence Number: 10935972
• Product Code: HTY
• UDI-Device Identifier: 00888867019638
• UDI-Public: 00888867019638
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 10043615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 08/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other