MAUDE Adverse Event Report: ORTHOFIX INC. FIREBIRD SFS; HOOK PUSHER

Model Number	51-7111
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were two instruments involved in the case.51-7111 hook pusher lot 30629-mg01 manufacture date; 07/01/2010.51-7111 hook pusher lot 30629-mh06 manufacture date; 08/06/2010.
Event or Problem Description
Information provided states that while trying to insert lumbar lamina hooks, surgeon stated hook kept falling off.Upon inspection both hook pushers were failing to close all the way resulting in a delay in the case.There were no adverse effects to the patient.

• Brand Name: FIREBIRD SFS
• Common Device Name: HOOK PUSHER
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6572119
• Report Number: 2183449-2017-00015
• Device Sequence Number: 11020998
• Product Code: LXH
• UDI-Device Identifier: 18257200046560
• UDI-Public: 18257200046560
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K081684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 51-7111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1