MAUDE Adverse Event Report: SYNTHES USA TI RIB HOOK

Catalog Number 04.641.001

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2013

Event Type  malfunction  

Event Description

Sait was reported during a vertical expandable prosthetic titanium rib (veptr) revision procedure, the titanium rib hook was being removed.The surgeon wanted to readjust/reposition the entire construct from the rib to pelvis.When the surgeon went to loosen the locking nut on top, it would not disengage properly and the nut broke off.It was reported that there were no fragments left in the patient.Another hook was used and seated properly to complete the procedure.There was a delay of 8 minutes in completing the procedure.The procedure was successfully completed with no patient injury reported.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A review of the device history records was not performed because no lot number was provided.Subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.Placeholder.

• Brand Name: TI RIB HOOK
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: w. lindenmuth ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3582879
• MDR Text Key: 21882459
• Report Number: 2520274-2014-00224
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• PMA/PMN Number: H030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2013
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 26