MAUDE Adverse Event Report: ARTHREX, INC. .062" X 7" LONG, GUIDE WIRE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number .062" X 7" LONG, GUIDE WIRE

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problems Exposure to Body Fluids (1745); Unspecified Tissue Injury (4559)

Event Date 01/03/2022

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a shoulder arthroscopy the pins got stuck in the cannulated spindle.With the pin being shorter than the spindle, it was impossible to remove it with pliers.While forcing to remove it, a nurse was injured, which resulted in a blood exposure accident.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: .062" X 7" LONG, GUIDE WIRE
• 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 ; 8009337001
• MDR Report Key: 14603630
• MDR Text Key: 293375513
• Report Number: 1220246-2022-05040
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867051737
• UDI-Public: 00888867051737
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/06/2022

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 Model Number: .062" X 7" LONG, GUIDE WIRE
• Device Catalogue Number: AR-8941-7
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other