MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTAL EXTENSION; PROTHESIS, RIB REPLACEMENT

Catalog Number 04.641.082

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that two titanium distal rods broke postoperatively.On (b)(6) 2014 the surgeon explanted two broken rods, two 35mm screws, four collars and four titanium nuts and replaced them with new hardware.It is unknown where the rods are broken.It is unknown what the original implant was for and the date of original implant is also unknown.It was reported that the patient visited the doctor ¿sometime last week¿ when the surgeon discovered the rods were broken.It is unknown how the surgeon discovered the broken rods.It is unknown if the devices will be returned.The patient was implanted with new hardware and surgery was successfully completed.This is 1 of 2 reports for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment not diagnosis.A review of the device history was performed.Device history records for components part 04.641.082, lot 5893763 were reviewed.No ncrs were generated during the production.Review of the device history record showed that there were no issues during manufacturing of the product that would contribute to this complaint condition.Lot 5893763 released to warehouse on january 28, 2009.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI DISTAL EXTENSION
• Type of Device: PROTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3688981
• MDR Text Key: 4302415
• Report Number: 2530088-2014-10036
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/06/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.082
• Device Lot Number: 5893763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention