MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PROXIMAL EXTENSION SIZE 6/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.096

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient id: (b)(6).Patient weight is unknown.Event date: unknown.Implant date: unknown.Manufacturing date: december 04, 2013.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Event Description

It was reported the patient had revision surgery for broken hardware on (b)(6) 2016.The proximal extension broke at the lock on the vertical expandable prosthetic titanium rib (veptr ii).All hardware was removed (proximal and distal extension and lock) and was replaced with a new set.The distal extension was removed intact.It was reported the patient was at the last hole on the distal extension and would have needed a replacement soon.The original implant date was unknown.There were no fragments or delay and the procedure was successful.It was reported the patient was fine during and after the procedure.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (ti proximal extension size 6/220mm radius, small, part number 04.641.096, lot number 7508151).The subject device was received with visible scratches, discoloration and part deformation indicating post-manufacturing damage or use.The complaint condition was confirmed.The relevant features of the subject device were measured and met specification.Per the previously reported device history record review and raw material review, the subject device met all required inspection and tests prior to release.The damage to the device is post-manufacture damage and was not related to the manufacture of the device.Additional investigation will be performed.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 evaluation was completed: the veptr ii titanium proximal extension, part 04.641.096, lot 7508151, was returned damaged.The female channel portion of the proximal extension that attaches to the distal extension was fractured.The railings of the channel were fractured and splayed outwards.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 complaint description stated that a patient implanted with veptr ii was experiencing pain.The proximal extension was observed to be broken and a revision surgery was performed.The proximal extension (part number 04.641.096, lot 7508151) was returned along with a distal extension (04.641.116) and a distraction lock (497.125) part.Part 04.641.096 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.A fracture analysis was performed on the fractured section of the proximal extension.The analysis revealed that the pattern of the fractured surface pattern is indicative of a static high load brittle failure.No material defects were observed.Although a definite root cause for the breakage could not be determined, the fracture analysis suggests that the breakage may have been the result of a static overload condition.No design related issues were identified.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.

Event Description

It was reported the patient felt differently and was having pain.There was nothing specific that triggered the event.The patient was reportedly ambulatory.

• Brand Name: TI PROXIMAL EXTENSION SIZE 6/220MM 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: 5496981
• MDR Text Key: 40216852
• Report Number: 2530088-2016-10078
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.096
• Device Lot Number: 7508151
• Other Device ID Number: (01)10705034750408(10)7508151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DISTRACTION LOCK (497.125)
• Patient Outcome(s): Required Intervention