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

Catalog Number	AR-9165K
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/27/2016
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.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 or Problem 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
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6037772
• Report Number: 1220246-2016-00430
• Device Sequence Number: 16383246
• Product Code: MDM
• UDI-Device Identifier: 00888867057951
• UDI-Public: 00888867057951
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: AR-9165K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2016
• 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