MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PROXIMAL EXTENSION SIZE 11/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.101

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that a patient was originally implanted with vertical expandable prosthetic titanium rib (veptr i) on unknown date.On (b)(6) 2014, patient was implanted with veptr ii from rib of t3 to iliac crest which is connected to the original veptr i implants.Patient is wheelchair bound and is moved by others from chair to bed everyday.On (b)(6) 2014, patient's parents noticed small open wound on posterior left side on patient's back.Upon taking x-rays on (b)(6) 2014, it was discovered that the proximal extension broke below the transition from sleeve to six millimeter proximal rod.On (b)(6) 2014, all existing implants were removed in the operating room.No implants were replaced or left in.Per x-ray review; there was a broken proximal rod that confirm the breakage were provided.Surgery was successfully completed without surgical delay this report is 1 of 1 for complaint com-(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.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Manufacturing evaluation investigation: a proximal extension 220-phi (04.641.101 / lot 6065304) has been received with post manufacturing damage consisting of scratches, nicks, discoloration, and gouges on several surface areas.The device is also broken into two (2) pieces.The complaint condition pertaining to the broken proximal extension was confirmed due to the observed post manufacturing damage.However, all relevant features to the part met specification; therefore, the complaint is unconfirmed from a manufacturing perspective.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 product development investigation was performed for the subject device (veptr ii ti proximal extension, part number 04.641.101).The part was returned broken with the rod portion separated from the channel portion.Instrumentation marks and gouging were observed on the rod portion, which are consistent with damages that occur during removal of the implants.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.Part 04.641.101 is a titanium proximal extension that attaches the superior attachment point at the rib to the distal extension.The drawing associated with the part was reviewed.The drawing calls out the appropriate dimensions, material and finishing processes for a successful design.The veptr ii titanium proximal extension, 04.641.101 / lot # 6065304, was returned broken with the rod portion separated from the channel portion.Instrumentation marks and gouging were observed on the rod portion, which are consistent with damages that occur during removal of the implants.The condition of the implant does not suggest any abnormalities related to the design of the device.The reported complaint is confirmed, although a root cause could not be identified.The breakage of the proximal extension most likely occurred due to excessive force applied on the implant.(b)(6).(b)(4).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 11/220MM 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: 4291131
• MDR Text Key: 5271578
• Report Number: 2530088-2014-10409
• 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
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.101
• Device Lot Number: 6065304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 52