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
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Unspecified Tissue Injury (4559)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220246-2022-05040
• Device Sequence Number: 5064990
• Product Code: MDM
• UDI-Device Identifier: 00888867051737
• UDI-Public: 00888867051737
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: .062" X 7" LONG, GUIDE WIRE
• Device Catalogue Number: AR-8941-7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown