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

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma# ¿ 510k: this report is for an unknown 90 mm length helical blade/unknown lot.Part and lot number are unknown; udi number is unknown.Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 that the patient had an original surgery performed for an inter-trochanteric femoral fracture on (b)(6) 2016.The patient presented with pain on an unknown date and revision surgery was performed on (b)(6) 2016.The construct that was explanted was one (1) 10 mm/130 mm degree, 170 mm length trochanteric femoral fixation nail, one (1) 90 mm length helical blade and one (1) 5.0 mm locking screw 30 mm.It was reported that the nail construct was removed with no issues and in good condition.The patient was revised to a depuy total hip replacement.The surgery was completed successfully, and the patient is reported in stable condition.This report is for an unknown 90 mm length helical blade.This is report 3 of 3 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 6215551
• MDR Text Key: 63634435
• Report Number: 2520274-2016-15811
• 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
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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
• Date Manufacturer Received: 12/05/2016
• 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