MAUDE Adverse Event Report: ARTHREX, INC. FEMORAL OPENING WEDGE; PLATE, FIXATION, BONE

Catalog Number	AR-13100-17.5
Health Effect - Clinical Code	Congenital Defect/Deformity (1782)
Date of Event	11/01/2005
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Lot number was not provided so device history record review cannot be performed.Additional information has been requested but not made available.Unknown device disposition.
Event or Problem Description
Legal: it was reported that patient was diagnosed with a right distal femoral valgus and underwent an opening wedge osteotomy on (b)(6) 2004.Operative report noted that as the surgeon approached the medial side, the distal aspect of the osteotomy was found to have fractured to the medial cortex.An arthrex ar-13100-17.5, femoral opening wedge osteotomy 17.5 mm plate was implanted to repair the osteotomy.Three arthrex ar-13303-2.4, osteotomy guide pins 2.4mm were also used.In addition, numerous screws from another manufacturer were used during the (b)(6) 2004 procedure.On (b)(6) 2005 patient underwent a revision surgery by another surgeon due to significant right distal femur non-union.Operative report notes this was confirmed by ct.During the revision surgery the arthrex plate from the (b)(6) 2004 procedure and all screws were explanted.The procedure was completed using another manufacturers product.

• Brand Name: FEMORAL OPENING WEDGE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6048440
• Report Number: 1220246-2016-00453
• Device Sequence Number: 549942
• Product Code: HRS
• UDI-Device Identifier: 00888867007611
• UDI-Public: 00888867007611
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K014155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 09/27/2016

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 Catalogue Number: AR-13100-17.5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/21/2016
• 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