MAUDE Adverse Event Report: ORTHOFIX INC. FIREBIRD NXG; TORQUE LIMITING HANDLE

Model Number 36-1512 (2)

Device Problem Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

Two devices returned for evaluation.It is unknown as to which device was used to final tighten set screws.36-1512 torque limiting handle (1) lot 200556-sh10 manufacture date 08/10/2016.36-1512 torque limiting handle (1) lot 101874-sb19 manufacture date 02/19/2016.

Event Description

Information provided states that patient experienced a fall post op and the forza ptc cage migrated, possibly due to improper torque during placement of set screws.Surgery was performed on (b)(6) 2017 to replace hardware on one side of construct.

• Brand Name: FIREBIRD NXG
• Type of Device: TORQUE LIMITING HANDLE
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 6639167
• MDR Text Key: 77717082
• Report Number: 2183449-2017-00018
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 18257200108824
• UDI-Public: 18257200108824
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 36-1512 (2)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 54 YR