MAUDE Adverse Event Report: SYNTHES, USA TI STERNAL LOCKING ANGLED PLATE/12 HOLES; PLATE,FIXATION,BONE

Catalog Number 460.039

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Pneumonia (2011); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient id: (b)(6).Patient weight is not available for reporting.Additional device product code used ¿ hwc.(b)(4).Exact date of implant is unknown.Implanted in (b)(6) 2015.Device is not expected to be returned for manufacturer review/investigation.(b)(4) used to capture additional medical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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.

Event Description

It was reported that on (b)(6) 2016, patient underwent revision surgery of sternal titanium plates.The patient had previously been revised to the sternal plates from a sternal zipfix back in (b)(6) 2015 but recently suffered from pneumonia and fractured his sternum again from coughing.When they opened the patient the plate was intact but it was found that a screw had completely come through the plate.It appeared that it had gone through a hole that had been contoured during the previous surgery.The patient was revised with a new plate and screw.The surgery was completed successfully with no reported delay.Concomitant devices reported: screws (quantity 11).This report is for one (1) sternal locking angled plate.This is report 1 of 2 for (b)(4).

• Brand Name: TI STERNAL LOCKING ANGLED PLATE/12 HOLES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES, USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6047782
• MDR Text Key: 58082943
• Report Number: 2520274-2016-15015
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 460.039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ELEVEN (11) UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention