MAUDE Adverse Event Report: ARTHREX, INC. .062" X 12" LONG, GUIDE WIRE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	.062" X 12" LONG, GUIDE WIRE
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dimension of the fully closed (compressed) packaging tube is 10.03 inches, where the length of the guide wire is 11.90 inches.When the ar-8941-12 device shifted during shipping, the packaging tube most likely became further compressed than the length of the guide wire, causing it to pierce through the end of the packaging tube.
Event or Problem Description
It was reported that the receiving clerk at the facility had sustained a hand penetration injury from the product that had punctured the skin and caused bleeding.The ar-8941-12 (guide wire, long), which is sold in a sealed plastic pouch, was shipped to the facility in a carton which contained additional products purchased.The guide wire had penetrated through its plastic pouch and the cardboard shipping box.The receiving clerk did not notice the guidewire sticking out of the box until the clerk moved the carton at which time the guidewire punctured the clerk¿s skin.There was no surgical case involvement.Arthrex has been provided pictures of the puncture wound, shipping box and device packaging.Additional information provided 8/29/2019: the receiving clerk received the cut on his left middle finger.Shortly after the incident, the small injury was cleaned and a band-aid was placed over it to stop the bleeding.There was no medical attention required and he did not have to miss any time from work.

• Brand Name: .062" X 12" LONG, GUIDE WIRE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8960718
• Report Number: 1220246-2019-01288
• Device Sequence Number: 2654564
• Product Code: MDM
• UDI-Device Identifier: 00888867051713
• UDI-Public: 00888867051713
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: .062" X 12" LONG, GUIDE WIRE
• Device Catalogue Number: AR-8941-12
• Device Lot Number: 10326597
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/04/2019
• 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