MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PROXIMAL EXTENSION SIZE 5/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.055

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that the proximal shaft of the prosthetic rib replacement device broke postoperatively and required revision surgery to address the breakage.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Unknown.It is unclear if the prosthesis broke on (b)(6) 2015, or if this was the date of the revision/explant surgery.Explant date is unknown but may have been (b)(6) 2015.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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

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.

Event Description

Additional information was received on june 8, 2015 reporting that the revision surgery was performed on (b)(6) 2015.The vertical expandable prosthetic titanium rib (veptr ii) device was explanted on this date.It is unknown when the device broke.

• Brand Name: TI PROXIMAL EXTENSION SIZE 5/500MM 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: 4814938
• MDR Text Key: 5894804
• Report Number: 2530088-2015-10467
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

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: 04.641.055
• Device Lot Number: 6142088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 06/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention