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

Catalog Number 04.601.000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Patient id/initials, age/date of birth and weight are unknown complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history 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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2015 a new veptr was stabilized, ranging from the left fifth lib to the ileum.On (b)(6) 2015 the surgery for adjusting veptr size was performed.On (b)(6) 2016 (b)(6) infection was noticed again.On (b)(6) 2016 the veptr, stabilized between the left fifth lib and the ileum, was removed.The patient has been well.The veptr treatment has been continued.This is report 1 of 9 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A device history record review was performed for the subject device lot number 6285205.Manufacturing location: (b)(4) (vendor: (b)4)).Date of manufacture: 21-jan-2010.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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Investigation summary: products were not returned.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.There is no allegation of device defect, deficiency or surgical technique error associated with this complaint.As there is no device malfunction alleged and no associated surgical technique error.Complained issue could not be confirmed.No pictures/ no x-rays were provided which would provide additional evidence.Complaint unconfirmed.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.

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6617267
• MDR Text Key: 76844982
• Report Number: 2530088-2017-10181
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819868601
• UDI-Public: (01)07611819868601(10)6285205
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.601.000
• Device Lot Number: 6285205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention