MAUDE Adverse Event Report: SYNTHES USA SMALL TI RIB HOOK CAP/STANDARD; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.007

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of onset for patient pain is unknown, but reportedly began in early (b)(6) 2015.Date of post-operative device migration is unknown.(b)(4).Per the facility, the complainant parts were discarded and are not available for evaluation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

It was reported that a vertical expandable prosthetic titanium rib (veptr) rod migrated and protruded through a patient's rib sometime following a scheduled lengthening procedure which took place on (b)(6) 2015.Prior to an office visit with the surgeon on (b)(6) 2015, the patient began reporting pain and discomfort.An x-ray taken during that office visit determined that the proximal point of fixation had cut through the rib.The patient was returned to the operating room on (b)(6) 2015 to have the small rib hook, small rib cap, and distraction lock removed.The devices were removed intact and the procedure was successfully completed with no medical intervention or surgical delay.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the products were not returned.It was reported that, following a lengthening procedure, the patient complained of pain and discomfort.An x-ray found that the proximal point of fixation had cut through the rib, necessitating a revision surgery.During the revision a small rib hook (04.641.002), small rib hook cap (04.641.007) and distraction lock (497.125) were removed intact and were noted to have not failed or broken.The implants were discarded by the hospital.Per the technique guide, the vertical expandable prosthetic titanium rib (veptr) ii system 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 and or at risk of developing thoracic insufficiency syndrome.¿ within the system, the rib hook attaches to the hook cap and proximal extension to support the superior rib, or the distal extension to support the inferior rib.The hook cap attaches to the rib hook to encircle the superior or inferior rib and the distraction lock connects the components (rib hook to hook cap, rib hook to rib hook extension, proximal extension to distal extension¿etc.).No definitive root cause was able to be determined as the devices were not available for return.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: SMALL TI RIB HOOK CAP/STANDARD
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5260390
• MDR Text Key: 32475436
• Report Number: 2520274-2015-17615
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention