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 Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient dob & weight not provided by reporter.Original implant date unknown.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Subject device has not been received.Without a correct lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received a review of the device history records has been requested.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 on an event in (b)(6) as follow: it was reported that on (b)(6) 2016, x-ray revealed that the reported lock to connect left veptr extension bar was dislocated before the planned veptr extension surgery.The surgeon confirmed that the left extension bar had been shortened due to the dislocated lock.During the extension surgery the surgeon adjusted the length to the extended right veptr bar by the surgical procedure.The surgeon commented that the dislocated lock on the left-side had been widened in comparison with the right-side lock on the surgery.No surgical delay was reported.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: patient weight is unknown.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: october 23, 2013.No non-conformance reports were generated during production.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.Date of post-operative device migration is unknown.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

This report is 1 of 2 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that:the following complaint device(s) was received by customer quality: one closure f/extension bar tan gold (part number: 497.125, lot number: 7507989, mfg date: 23oct2013; one ti distraction lock (part number: 497.125, lot number: 7742861, mfg date: 31jul2014; 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 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 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: 5400590
• MDR Text Key: 37179935
• Report Number: 2520274-2016-10588
• 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,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: 7507989
• Other Device ID Number: (01)07611819747289(10)7507989
• 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: 01/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/09/2016; 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR