MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PROXIMAL EXTENSION SIZE 6/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.056

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The subject device is expected to be returned to the synthes manufacturer for evaluation.(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that revision surgery was performed on (b)(6) 2015 to explant and revise a broken prosthetic rib replacement device.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

A product investigation was completed: the veptr ii titanium proximal extension, part 04.641.056, lot 6713249, was returned.Marks and scratches were observed on the returned device.The bendable proximal end of the implant was either broken or modified during surgery.Both edges of the notch for distraction locks at the distal extension of the device are broken.The veptr ii (vertical expandable prosthetic titanium rib) system is intended 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.The veptr ii devices are attached perpendicular to the patient¿s natural ribs, or to the lumbar vertebra or ilium.Part 04.641.056 is a titanium proximal extension that attaches the superior attachment point (rib hook) to the distal extension.The complaint description stated that the derive titanium proximal extension was broken postoperatively.Marks and scratches were observed on the device and a portion of the device was broken at the part where it connects to the distal extension.The relevant drawings were reviewed.The drawings call out the appropriate dimensions, material and finishing process for a successful design.An exact cause for the reported complaint could not be determined.The breakage most likely occurred due to an improper post operational activity.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.

• Brand Name: TI PROXIMAL EXTENSION SIZE 6/500MM 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: 5239947
• MDR Text Key: 31750383
• Report Number: 2530088-2015-10701
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.056
• Device Lot Number: 6713249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR