MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID GUIDEWIRE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-9165K

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 09/27/2016

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.No device malfunction identified.Lot number was not provided so device history record review cannot be performed.As described in the event, after the optional reaming step, the surgeon forgot to remove the guide wire.With the guidewire not visible the surgery continued on, otherwise successfully.The patient was x-rayed in pacu but the x-ray was not read in a timely fashion.The patient was moved from pacu to the floor unit.When the radiologist read the x-ray he discovered that it appeared there was a foreign pin protruding out of the patient's back.After safety was established, the orthopedic surgeon was able to pull the protruding wire out of the patient's back with pliers.No additional incision was necessary.Device reported to be discarded by user.

Event Description

It was reported that during a reverse total shoulder procedure, the ar-9165k guidewire had been removed after reaming.The surgeon needed to do the optional reaming step for this procedure and he put the ar-9165k back in.After the optional reaming step the surgeon forgot to remove the guidewire.He then used the trinity baseplate impactor to impact the implant.The trinity impactor is cannulated so the surgeon slid the guide over the wire.Once the impactor was in place the wire was no longer visible.Surgeon proceeded to drill, tap and implant the central screw through the trinity impactor.With the guidewire not visible the surgery continued on, otherwise successfully.The patient was x-rayed in pacu but the x-ray was not read in a timely fashion.The patient was moved from pacu to the floor unit.When the radiologist read the x-ray he discovered that it appeared there was a foreign pin protruding out of the patient's back.The patient was transferred back to pacu.In pacu a cardiothoracic surgeon was consulted to ensure there were no internal issues.After safety was established, the orthopedic surgeon was able to pull the protruding wire out of the patient's back with pliers.No additional incision was necessary.

• Brand Name: UNIVERSAL GLENOID GUIDEWIRE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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 Key: 6037772
• MDR Text Key: 57784258
• Report Number: 1220246-2016-00430
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867057951
• UDI-Public: 00888867057951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 09/27/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: AR-9165K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other