MAUDE Adverse Event Report: SYNTHES BRANDYWINE 90 DEG TI S-HOOK/LEFT; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.601.001

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).A review of the device history records has been requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 europe reports an event in (b)(6) as follows: it was reported that a veptr hook broke post-operatively on an unknown date approximately two (2) years after initial implantation.The device breakage was determined by x-ray on an unknown date.The hook fixed on the ilium broke.The initial surgery occurred on (b)(6) 2014, however, the surgeon distracted veptr earlier in 2016 on an unknown date.A revision surgery occurred on an unknown date and the broken device was removed.It was not determined how the patient was revised or if fragments remained implanted.Surgical delay or additional medical intervention is unknown.Patient status is unknown this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Part 04.601.001, lot 7314112: manufacturing site: (b)(4).Manufacturing date: april 17, 2013.Review of device history records show that there were no issues during the manufacture of the product that would contribute to this 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis a product investigation was performed.It was reported that a surgeon treated a patient, on (b)(6) 2014, having distracted veptr earlier this year.In this week the ala hook fixed on the ilium broke.The surgeon needed to change the hook to continue the treatment.The ala hook broke post-operatively, 2 years after the implant surgery.The 90 degree titanium s-hook left (04.601.001, 7314112) is a component of the veptr ii system instrument and implant set (01.641.001).The veptr ii (vertical expandable prosthetic titanium rib) is utilized 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 or at risk of developing thoracic insufficiency syndrome.The complaint condition was confirmed as the returned s-hook was received broken.As part of this investigation a visual inspection, drawing review, root cause analysis, and risk management assessment were performed.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the available information there is no way to definitively determine the root cause of the complaint condition.It is stated in the complaint description that the returned s-hook broke two years after it was implanted.It is possible that the s-hook broke due to being exposed to an unexpected force.The patient was very young and could have contributed to the implant breakage due to non-compliance or not properly avoiding complications due to a lack of caution.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 90 DEG TI S-HOOK/LEFT
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6167251
• MDR Text Key: 62143063
• Report Number: 2530088-2016-10345
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819868618
• UDI-Public: (01)07611819868618(10)7314112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142587
• 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: 11/18/2016

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: 04.601.001
• Device Lot Number: 7314112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2017; 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 13