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

Event Type  Injury  

Event Description

The revision surgery of a vertical expandable prosthetic titanium rib system was reported.The patient was originally treated for thoracic insufficiency syndrome on (b)(6) 2012.It was reported that on an unknown date, the patient may have complained of pain and it was discovered via x-rays on (b)(6) 2014 that the s-hook at the bottom of the construct was broken.The surgeon decided to explant the s-hook and the two parallel connectors and implanted an s-rod and two new parallel connectors.It was reported that the s-hook was broken at the top straight rod of the hook.This is report 1 of 1 for (b)(4).This report is for s-hook.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history record revealed no complaint related anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.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.

Manufacturer Narrative

Additional narrative: weight reported as (b)(6).A manufacturing evaluation was completed: the device was received with post manufacturing damage consisting of dents, nicks, and gouges on several surface areas and is broken into two pieces.The severed region of the rod occurred in the area where the ti parallel connectors were used.These items are consistent with use.There was no issues identified that pertained to the complaint condition; the device was received with post manufacturing damage so one of the features could be properly evaluated but that feature would not have impacted the complaint condition.All other features relevant to the part met specification; there, the cause is unconfirmed.The complaint condition pertaining to the broken s-hook was confirmed.The feature that was not able to be evaluated now was verified during final inspection during manufacturing.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

(b)(4) a product development evaluation was performed for the subject device.The subject device, part number 04.601.001, left 90 degree s-hook, lot # 64865338, was received with numerous dents and a portion of the rod is broken in two pieces.The location of the two primary dents correspond with the mating ti parallel connector was attached and the fractured surface appears to have occurred at the transition zone between the connector and the rod.The veptr 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 devices are attached perpendicular to the patient¿s natural ribs, or to the lumbar vertebra or ilium.Part 04.641.001 is an s-hook used with the distal extension and connector to attach to the ilium.The drawing associated with the part was reviewed.The drawing calls out the appropriate dimensions, material and finishing processes for a successful design.The returned left 90 degree s-hook, 04.641.001/ lot # 64865338, has been received with numerous dents and a portion of the rod is broken in two pieces.The location of the two primary dents correspond with the mating ti parallel connector was attached and the fractured surface appears to have occurred at the transition zone between the connector and the rod.No design related issues were identified with the returned part.The breakage of the s-hook most likely occurred due to excessive force applied on the implant.The complaint condition was confirmed.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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3720687
• MDR Text Key: 4335095
• Report Number: 2530088-2014-10045
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• 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: 6486538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 42