MAUDE Adverse Event Report: SYNTHES USA; ROD,FIXATION,INTRAMEDULLARY

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930); Joint Swelling (2356)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown blade/unknown lot number.Unknown if device is/not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and 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 developed an infection and underwent removal of hardware.A patient, who was implanted with a trochanteric fixation nail (tfn), presented with redness and swelling along the right hip.He was diagnosed with infection and underwent removal of tfn, a lag screw and two dual force screws on (b)(6) 2016.A culture was taken; results are pending and will not be available.It was noted that this was the patient's third procedure.There was no surgical delay.It was reported that the procedure was successfully completed.Patient outcome is unknown.There are no plans at this time to implant other devices.No additional information available.This report is 4 of 4 for (b)(4).

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

Device pro code was supposed to be hsb not hwb.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.

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5462375
• MDR Text Key: 39089189
• Report Number: 2520274-2016-11328
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/07/2016; 03/08/2016
• 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