MAUDE Adverse Event Report: SYNTHES USA; PIN, FIXATION, SMOOTH

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

Patient Problems Rheumatoid Arthritis (1724); Inflammation (1932); Pain (1994); Burning Sensation (2146)

Event Type  Injury  

Event Description

It was reported that a patient suffered a fracture of the elbow and underwent a surgical procedure on (b)(6) 2012 where a 7.3mm hexagonal compression screw, 7.3mm compression rod, and a charlie-wire (c-wire) were implanted.The patient reportedly woke from the procedure with severe inflammation of the elbow, full body pain, and a burning sensation in her fingers and toes.Within one week, she reportedly developed full body rheumatoid arthritis (ra) for which she was treated with humira and (more recently) leflunomide.On (b)(6) 2015, the hardware in the elbow was removed.At this time, the patient, although still taking her prescribed ra medications, is mostly symptom free.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Patient reported symptoms upon waking from surgery on (b)(6) 2012.This report is for one (1) unknown 7.3mm c-wire.(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.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.

Manufacturer Narrative

(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PIN, FIXATION, SMOOTH
• 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: 4694355
• MDR Text Key: 20019741
• Report Number: 2520274-2015-12930
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

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: 05/29/2015
• Initial Date FDA Received: 04/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2015
• 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
• Patient Weight: 62