MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PROXIMAL EXTENSION SIZE 4/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.054

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age, dob & weight not provided.Device not explanted.Device is not expected to be returned for manufacturer review/investigation, was disposed of.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr not completed, a review of the device history records has been requested.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 on an event in (b)(6) as follows: it was reported that a patient, who has the jarcho-levin syndrome, had vertebral abnormalities.On (b)(6) 2015, the patient underwent a surgery.The doctor used the proximal extesion rad, measured and passed to make the cut, needed to angle to make the fit precisely.During this process, the proximal extesion rad was angled more than necessary and broke.The device was no longer possible to use and has been replaced by another.Patient outcome good / no delay in surgery reported.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4): manufacturing date: december 10, 2012.Part 04.641.054, lot 7108583: a review of the device history records (dhr) did not contain any anomalies or non-conformance reports.Dhr records for the raw material lot indicate that the raw material underwent all required inspection and test requirements with no nonconformities reported.Review of the device history record(s) showed that there were no issues during the manufacture 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: TI PROXIMAL EXTENSION SIZE 4/500MM 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: 5505542
• MDR Text Key: 40534199
• Report Number: 2530088-2016-10085
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.054
• Device Lot Number: 7108583
• Other Device ID Number: 01)07611819353008(10)7108583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1