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

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

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Patient weight is not provided for reporting.Date of event is unknown.This report is for one (1) unknown helical blade.Part#, lot# and udi # is not available.Device was not reported to have been explanted.It is unknown if the device was explanted.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown helical blade.Pma/510(k) number is not available.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 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.

Event Description

It was reported by the patient that he had a trochanteric fixation nail tfn procedure completed on (b)(6) 2016.Since then, he acquired a skin rash in (b)(6) 2016 that started in his upper back.His dermatologist is requesting that he obtains the material make-up of his implants in order to see if he is allergic to the alloys.This report is for one (1) unknown helical blade.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

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.

Event Description

Patient reported the rash has been diagnosed.Diagnosis is an autoimmune skin disease called pemphigus vulgaris.It has been determined by the physician that the condition is separate from any implication of the surgery or implants.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6311958
• MDR Text Key: 66817717
• Report Number: 2520274-2017-10425
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• 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