MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP; PLATE, FIXATION, BONE

Model Number KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during a distal clavicle fracture and ac joint stabilization procedure the surgeon had placed an ar-2658tr, knotless clavicle tightrope and was unhappy with the position of the distal button.Surgeon and sales rep discussed after that the surgeon most likely drilled out the medial cortex of the corocoid as the button was position medial to the coracoid.Surgeon removed the proximal button and suture but was unable to remove the distal button and chose to leave it in the soft tissue medial to the coracoid.After re-drilling, the surgeon attempted to implant another knotless clavicle tightrope.The surgeon struggled to find his tunnel in the coracoid.After trying to pull the inserter out, the distal button became dislodged in the clavicular tunnel.Surgeon and sales rep discussed after the surgeon may have used too much force on the inserter and the button came loose from the threaded stylet.The surgeon removed the proximal button and suture but chose to leave the distal button in the clavicular still tunnel.The surgeon then completed the procedure and achieved adequate fixation with a suture cerclage instead.Nothing will be returned for evaluation.The distal button from both devices remains in the patient and the remaining portions with proximal buttons were discarded by staff at time of procedure.

• Brand Name: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Type of Device: PLATE, FIXATION, BONE
• 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 ; 8009337001
• MDR Report Key: 10561289
• MDR Text Key: 207775074
• Report Number: 1220246-2020-02182
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867271814
• UDI-Public: 00888867271814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Device Catalogue Number: AR-2658TR
• Device Lot Number: 10378655
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: No
• 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