MAUDE Adverse Event Report: ARTHREX INC. PROXIMAL TENODESIS IMPLANT SYSTEM REV:0; PIN, FIXATION, SMOOTH

Model Number AR-2290

Device Problems Migration or Expulsion of Device (1395); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2017

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.Device history record review revealed nothing relevant to this event the device was received and an evaluation was conducted.Complaint confirmed.The evaluation revealed that the fiberloop was broken-off.Three of the fiberloop strands ends were frayed.This type of event is typically caused by nicking the suture with another instrument and/or fraying from sharp edge of the bone tunnel.This is the first complaint of this type for this part/lot combination.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 that during a proximal biceps tenodesis case, the fiberloop from the proximal tenodesis implant system popped and got cut after the button had been inserted and when the surgeon was tensioning the biceps down to the bone.The case was completed with a second implant system from a different lot with no adverse effect to the patient.Follow up information: the button from the implant system was retrieved.There was some suture from the implant system that was attached to the biceps tendon that the surgeon did not cut out.Surgeon just sewed a new loop around them.Button and some suture remnant are being returned for evaluation.

• Brand Name: PROXIMAL TENODESIS IMPLANT SYSTEM REV:0
• 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 Key: 7086014
• MDR Text Key: 93806128
• Report Number: 1220246-2017-00462
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867026698
• UDI-Public: 00888867026698
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/06/2017

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: 06/30/2022
• Device Model Number: AR-2290
• Device Lot Number: 10155722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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