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

Catalog Number 04.601.000

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that a patient had the original surgery performed on march 2012 using vertical expandable prosthetic titanium rib (veptr) devices.During a follow up x-ray obtained in the last week of (b)(6) 2014, it was found that the distal vertical expandable prosthetic titanium rib (veptr) rod broke off in the parallel connector and a s-hook was also found to be broken.A surgical revision was performed on (b)(6) 2014 and new parts implanted.No surgical delay.All pieces retrieved.This is report number 2 of 2 for (b)(4).

Manufacturer Narrative

Actual patient weight reported: (b)(6).Implant date reported as (b)(6) 2012.Subject device has been received and is currently in the evaluation process.Review of manufacturing records has been requested.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

Additional narrative: product investigation evaluation: right 90 deg ti s-hook (04.601.000 / lot 5026733) the return product was observed without magnification and found to exhibit scratches, tool indentations and round indentations on the surface of the part.The damaged end surfaces of the subjected part and rod piece secured by the ti parallel connector.It appears the broken end of the rod is a mirror image of the left out piece connected in parallel connector and confirmed that the two damaged rod ends were of the same continuous s-hook/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 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.The returned part is an s-hook used with the distal extension and parallel connector to attach to the ilium.The system includes 4 s-hooks.The drawing associated with the part was reviewed.The drawing calls out the appropriate dimensions, material and finishing processes for a successful design.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.

Manufacturer Narrative

A manufacturing investigation action was conducted/performed.The report indicates that: the returned item were verified as meeting established manufacturing specifications.Although the as received condition of the item was confirmed to be broken, there are no indications that manufacturing of the item contributed to the complaint condition reported as broken.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).Device history records showed that there were no issues during the manufacturing 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.

• Brand Name: 90 DEG TI S-HOOK/RIGHT
• 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: 4259218
• MDR Text Key: 5014175
• Report Number: 2530088-2014-10381
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2014

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: 04.601.000
• Device Lot Number: 5026783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2014; 04/13/2015; 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 18