MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 125MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.310S

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

Patient Problems Rash (2033); Local Reaction (2035); Swelling (2091); Alteration In Body Temperature (2682)

Event Type  Injury  

Manufacturer Narrative

Symptom onset reportedly began in 2012.(b)(4).At this time, the complainant parts have not been explanted.The complainant parts have not been removed and, therefore, will not be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4).Manufacturing date: april 22, 2009.Expiration date: march 31, 2018.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or non-conformities noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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 procedure to treat a femur fracture on (b)(6) 2010.At the time, the patient was implanted with 12mm/130 degree titanium cannulated trochanteric fixation nail, an 11.0mm titanium helical blade, and a 5.0mm titanium locking screw.At an unknown time in 2012, the patient developed a ¿fiery red¿ rash (or similar skin condition) in the area surrounding the around the hip coupled with a high fever and flu-like symptoms.The reported condition comes and goes, with the affected area growing at each recurrence.The reporter confirmed that the devices are still implanted in the patient with no explant procedure scheduled at this time.This report is 2 of 3 for com-(b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 125MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5772586
• MDR Text Key: 48870144
• Report Number: 3003506883-2016-10109
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/20/2016

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
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 456.310S
• Device Lot Number: 6119639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention