MAUDE Adverse Event Report: SYNTHES (USA) HELIX BLADE 85MM; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 282.236

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/26/2014

Event Type  Injury  

Event Description

It was reported during an open reduction internal fixation of a hip fracture on (b)(6) 2014 using the dhs dcs dynamic hip and condylar screw system, the surgeon was impacting the helical blade and the blade pushed through the femoral head.The surgeon used a removal tool to back out the blade and put a new plate back into place using the same helical blade.A 10 minute surgical delay was reported, there was no patient harm and the procedure was successfully completed.It was noted that the physician did use the plate alignment key prior to insertion so all of the measurements were correct.It is also confirmed that there are no allegations or complaints against the plates, devices are not available for return.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HELIX BLADE 85MM
• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• 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: 3884277
• MDR Text Key: 4567865
• Report Number: 2520274-2014-12021
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK981757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/26/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 282.236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2014
• Initial Date FDA Received: 06/19/2014
• 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 Age: 87 YR