MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PROXIMAL EXTENSION SIZE 9/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.059

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that a proximal extension from a vertical expandable prosthetic titanium rib (veptr) implant was discovered broken post-operatively.The patient was originally implanted with a veptr implant on an unknown date at t-2 to the pelvis.During a routine expansion surgery, the surgeon discovered that the proximal extension rod was sheared/broken via x-ray.The surgeon implanted the patient with a new rod and the surgery was successfully completed.It was reported that the broken rod caused a forty-five minute to one hour time delay in the normal surgery time.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis the investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4): device history review: the reported product lot was produced at the (b)(4) facility on august 27, 2010.A review of the device history record(s) of the reported product lot, sub-components, and raw material from which it was produced showed that there were no non-conformities reported for the raw material or during the manufacture of the reported product lot that would contribute to the complaint condition.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing investigation was conducted.The report indicates that the rod portion of the device is bent and approximately 59mm has been removed from its overall length.There are deep indentations and anodize removal in several areas around the circumference of the rod surface.The channel portion of the device has the tabs on each side of the channel ripped from the body of the device and curled outward.There are four rub marks with anodize removal of the inside of the channel which indicate four separate length adjustments that were made during use.There are heavy nicks, dents, and scratches on the outside surfaces and edges and hole areas of the channel.All observed alterations and noted damage pertaining to the device condition are post manufacturing items.Device inspection during manufacturing is 100% for all pertinent features.This device was re-measured (post manufacturing) for conformance of the features related to the complaint condition.Results are recorded with the report.The l5 upper step width could be measured because of structural damage to the device.The complaint is confirmed for the condition of ¿broken¿, however is unconfirmed from a manufacturing prospective.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product evaluation was performed.The investigation of the complaint articles indicates that: the veptr ii device is designed to mechanically stabilize and distract the thorax to correct three dimensional thoracic deformities and provide improvement in volume for respiration and lung growth in infantile and juvenile patients diagnosed with thoracic insufficiency syndrome.The veptr ii devices are attached perpendicular to the patient¿s natural ribs, or to the lumbar vertebra or ilium.The breakage of the proximal extension most likely occurred due to excessive force applied on the implant.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI PROXIMAL EXTENSION SIZE 9/500MM 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: 3888993
• MDR Text Key: 4673942
• Report Number: 2520274-2014-12050
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142587
• 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,Followup,Followup,Followup,Followup
• Report Date: 05/27/2014

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: 04.641.059
• Device Lot Number: 6465489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 06/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/23/2014; 02/27/2015; 03/10/2015; 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention