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

Catalog Number 460.039

Device Problems Break (1069); Device Slipped (1584)

Patient Problems Fall (1848); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

It is unknown when the postoperative plate loosening and screw breakage occurred.The patient reportedly fell on (b)(6) 2015, but it is unknown if the device issue occurred prior to or as a result of the fall.(the surgeon has attributed the screw breakage to the fall).Additional product codes for this report include hwc.(b)(4).The complainant parts were returned to the patient and are not available for manufacturer evaluation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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 a patient originally underwent a sternal plating procedure on (b)(6) 2015.Approximately one (1) month later, on (b)(6) 2015, the patient fell and thereafter began experiencing sternal pain.The patient returned to the operating room for sternal revision on (b)(6) 2016.Upon entry into the area, the surgeon discovered that the sternum had healed despite the plates on both sides being loose.Additionally, it was discovered that one (1) of the twelve (12) implanted screws had a broken head; the other eleven (11) screws remained intact.The surgeon determined that the head of the screw had broken off due to the fall.The surgeon was able to easily remove the plates, the intact screws, and the head of the broken screw.The threaded portion of the broken screw was left in the patient.The surgery was completed without further complications and with no time delay.No additional information is available.This report is 1 of 3 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 (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5377685
• MDR Text Key: 36338196
• Report Number: 2520274-2016-10309
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• 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?: Yes
• Date Manufacturer Received: 01/04/2016
• 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
• Patient Outcome(s): Required Intervention