MAUDE Adverse Event Report: ARTHREX, INC. BIPLANAR ALIGNMENT MOUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BIPLANAR ALIGNMENT MOUNT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
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.
Event or Problem Description
It was reported that during an ibalance hto case, the ar-13419-02 collet nut cross-threaded onto the ar-13420-01 biplanar alignment mount and could not be removed.The ar-13419-01 hinge pin and ar-13420-02 biplanar alignment bar were also part of the device.Because the nut could not be removed, they could not put in another guide to drill the keyhole.The devices were removed from the patient and they used freehand for the keyhole drill holes and the osteotomy.The implant was done successfully to complete the case.There was an additional incision needed on the lateral side of the fibia to create an additional pivot for the osteotomy.

• Brand Name: BIPLANAR ALIGNMENT MOUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9700043
• Report Number: 1220246-2020-01660
• Device Sequence Number: 2284003
• Product Code: LXH
• UDI-Device Identifier: 00888867012523
• UDI-Public: 00888867012523
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/12/2020

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: BIPLANAR ALIGNMENT MOUNT
• Device Catalogue Number: AR-13420-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other