MAUDE Adverse Event Report: SYNTHES USA 3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES; CERCLAGE FIXATION

Catalog Number 413.584E

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).Without a lot number the device history records review could not be completed.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.

Event Description

It was reported that a patient had a sternal reconstruction surgery on (b)(6) 2016.The patient was brought back in on (b)(6) 2016 for an evaluation due to pain.The patient had undergone cardiac surgery on an unknown date.The surgeon decided to remove all the existing intact hardware four (4) plates and twenty-five (25) locking screws.It was then noticed that the patient also had a nonunion of the sternum.The patient was revised to a construct which included sterile plates and screws.It was reported that the procedure was successfully completed with no surgical delay and no patient harm.This report is 10 of 29 for (b)(4).

• Brand Name: 3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES
• Type of Device: CERCLAGE FIXATION
• 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: 6119510
• MDR Text Key: 60620034
• Report Number: 2520274-2016-15463
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010943
• 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: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.584E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 109