MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI RIB SLEEVE-SIZE 9 220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.108

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: breakage of vertical expandable prosthetic titanium rib (veptr) implant.The veptr system was extended to the last hole half year ago.A revision surgery is planned soon.Since friday, (b)(6) 2014, the patient suffers from changed body position and has pain.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Implant date was in 2009, exact date is unknown.Device is still implanted in patient.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4): device evaluated by manufacturer- no information.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A medical / surgical intervention was needed, a revision surgery was done on an unknown date.(b)(4).

Manufacturer Narrative

A manufacturing investigation was conducted.The report indicates that: the measurable dimensions of the extension bar were checked and found to be in compliance with the technical drawings and ao/asif specification.Material the examination of the raw material testing certificate and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard (iso 5832-11).Conclusion the visual examination shows indentation which could result from constructions mantling or dismantling.The extension bar is on one end lacerated and bent.Without further details afterwards it is not possible to determine what kind of mechanical force impact on the implant and the cause of the failure mode.No failure in material could be detected.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

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device history records (dhr) for part 497.108, lot 6033384, indicates that the reported product was manufactured at the brandywine manufacturing facility.The product lot was manufactured in accordance with all established requirements with no nonconformities reported.The product lot underwent all specified inspection requirements with no product nonconformities reported.The product was produced from raw material in accordance with established specifications.Device history records for raw material indicate that the raw material was received at the brandywine facility and indicate that the raw material underwent all specified inspection and testing requirements and was found to meet all established criteria for acceptance and use as intended.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 RIB SLEEVE-SIZE 9 220MM RADIUS
• 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: 3965447
• MDR Text Key: 4631177
• Report Number: 2520274-2014-12901
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.108
• Device Lot Number: 6033384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention