MAUDE Adverse Event Report: SYNTHES (USA) HELIX BLADE 100MM; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 282.239

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It is reported that there was a failed controlled collapse of a helix blade.The helix blade was reported to be bent.The revision surgery was scheduled for (b)(4) 2014, approximately two weeks after the original surgery and the damaged implant was successfully removed.The whole assembly consisting of a helix blade, locking compression plate and three cortex screws was replaced with new implants.The revision surgery was successfully completed.The patient status was reported as ok.No delay in the surgical time has been reported.This report is 2 of 5 (b)(4).

Manufacturer Narrative

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.

• Brand Name: HELIX BLADE 100MM
• 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: 4059301
• MDR Text Key: 4906856
• Report Number: 2520274-2014-13434
• 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: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 282.239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2014
• 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: 69 YR