MAUDE Adverse Event Report: ORTHOFIX INC PHOENIX SFS SYSTEM; UNIVERSAL TAB REMOVAL HOOK

Model Number	20-0280
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that during a case one of the prongs broke on the universal tab remover.This delayed the case and the prong remains in the patient.

• Brand Name: PHOENIX SFS SYSTEM
• Common Device Name: UNIVERSAL TAB REMOVAL HOOK
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5580998
• Report Number: 3008524126-2016-00009
• Device Sequence Number: 11006357
• Product Code: NKB
• UDI-Device Identifier: 18257200028474
• UDI-Public: 18257200028474
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2016

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: 20-0280
• Device Lot Number: 36680-PD09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2016
• Initial Report FDA Received Date: 04/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR