MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTRACTION LOCK; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.125

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient weight is unknown.Date of post-operative device migration is unknown.Original implant procedure is unknown.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the device history records has been requested and is pending completion.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient was scheduled to undergo a veptr extension procedure on (b)(6) 2016.Pre-operative x-ray images revealed that the lock connecting the left veptr extension bar had dislocated and migrated.The surgeon confirmed that the left extension bar shortened due to the dislocated lock.During the extension procedure, the surgeon adjusted the length to the extended right veptr bar.The surgeon commented that the dislocated lock on the left-side had widened in comparison to the right-side lock.No surgical delay was reported.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: both implants can be used in both vertical expandable prosthetic titanium rib (veptr) and vertical expandable prosthetic titanium rib ii (veptr ii) systems.Both systems are 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.¿ the lock connect the components (rib hook to hook cap, rib hook to rib hook extension, proximal extension to distal extension¿etc.) together.Upon visual inspection of the complaint device it can be seen that the distal ends of the implant bent outward resulting in the lock from disengaging from the construct.A definitive root cause was unable to be determined however the complaint condition is consistent with stresses imposed on the device due to patient activity, patient growth, and or unusual stresses imposed on the device during implantation.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition, this complaint is confirmed.Device history records was conducted.The report indicates that the: manufacturing date: 31jul2014 p/n 497.125, lot # 7742861 did not contain any ncrs or anomalies.(b)(4) pcs accepted/conforming.In addition, the following lot was reviewed: 6660255.Dhr records for raw material p/n 24003, tialnbfi19.05x10.00, lot# 6660255 indicates that the raw material underwent all required inspection and test requirements.In conclusion, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI DISTRACTION LOCK
• 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: 5419991
• MDR Text Key: 37837672
• Report Number: 2530088-2016-10023
• 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: 01/15/2016

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: 497.125
• Device Lot Number: 7742861
• Other Device ID Number: (01)10705034787480(10)7742861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR