MAUDE Adverse Event Report: ARTHREX, INC. OSTEOTOMY GUIDE PIN, 3.0MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	OSTEOTOMY GUIDE PIN, 3.0MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
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 requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a case, the 3.0 pin became stuck in the osteotomy guide.The surgeon had to perform a free-handed cut to complete the case.*additional information requested.Additional information provided 8/7/2018: this event occurred during a distal femoral opening wedge osteotomy, the 3.0 osteotomy guide pin, ar-13303-3.0 became stuck as the surgeon was trying to remove it from the guide.The devices were used per dfu technique.

• Brand Name: OSTEOTOMY GUIDE PIN, 3.0MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7827349
• Report Number: 1220246-2018-00609
• Device Sequence Number: 2336189
• Product Code: MDM
• UDI-Device Identifier: 00888867010710
• UDI-Public: 00888867010710
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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: OSTEOTOMY GUIDE PIN, 3.0MM
• Device Catalogue Number: AR-13303-3.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-13305, LOT 02025005, OSTEOTOMY GUIDE ASSEMBLY
• Outcome Attributed to Adverse Event: Other