MAUDE Adverse Event Report: ACUTE INNOVATIONS, LLC ACUTIE II; CERCLAGE, FIXATION

Model Number	ACUTIE II
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Event or Problem Description
Plate was removed from patient because the surgeon apparently did not cut the wire short enough and the patient was having some discomfort.Said they always cut the wire as short as they can but this particular patient was very thin, so they're thinking this may have played a part.

• Brand Name: ACUTIE II
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): ACUTE INNOVATIONS, LLC; 21421 nw jacobson road; suite 700; hillsboro OR 97124
• MDR Report Key: 6170559
• Report Number: 3005670412-2016-00014
• Device Sequence Number: 828130
• Product Code: JDQ
• UDI-Device Identifier: 10814493010753
• UDI-Public: 10814493010753
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2016

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: Physician
• Device Model Number: ACUTIE II
• Device Catalogue Number: STW1104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2016
• Initial Report FDA Received Date: 12/13/2016
• 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: Required Intervention