MAUDE Adverse Event Report: ORTHOFIX INC ASCENT POCT SYSTEM; DOMED SET SCREW DRIVER, ASCENT POCT

Model Number	65-1064
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that during a revision case the surgeon was having difficulty with the set screw driver for final tightening resulting in a delay in completing the case.The surgeon used a universal removal set to perform final tightening.
Event or Problem Description
Information provided states that during a revision case the surgeon was having difficulty with the set screw driver for final tightening resulting in a delay in completing the case.The surgeon used a universal removal set to perform final tightening.

• Brand Name: ASCENT POCT SYSTEM
• Common Device Name: DOMED SET SCREW DRIVER, ASCENT POCT
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5637198
• Report Number: 3008524126-2016-00011
• Device Sequence Number: 10765244
• Product Code: KWP
• UDI-Device Identifier: 18257200063307
• UDI-Public: 18257200063307
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K111183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 65-1064
• Device Lot Number: 17051-LD07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 07/07/2016
• 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
• Patient Age: 66 YR