MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTAL EXTENSION SIZE 13/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.123

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that a patient was implanted with veptr expansion device for thoracic insufficiency on (b)(6) 2014.He was already scheduled for a routine six-month expansion procedure, but reported that he heard a 'pop' when walking on (b)(6) 2014.The patient was returned to the operating room on (b)(6) 2014 where x-rays confirmed the right medial expansion device was broken on the distal implant.The surgeon removed the broken portion of the distal extension, and replaced it with another distal extension of the same size.The procedure was completed.Clinical review by the manufacturer of provided x-rays confirmed a broken distal extension.Patient status / outcome is "reported well".This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history record for raw material lot # 6844024 was reviewed.Review of inspection requirement showed that the material conformed to all dimensional and chemical content analysis specifications.Review of lot # 6844024 shows raw material lot was processed within specifications.Component part # 04.641.123, lot # 7308028: no nonconformance reports 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.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 SIZE 13/220MM RADIUS
• Type of Device: PROSTHESIS, 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: 3971066
• MDR Text Key: 4635537
• Report Number: 2530088-2014-10198
• 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: 07/02/2014

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: 04.641.123
• Device Lot Number: 7308028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2014
• Initial Date FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70