MAUDE Adverse Event Report: SYNTHES ELMIRA DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM

Catalog Number 280.900

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

It was reported during a surgical procedure to repair an intertrochanteric fracture, a dynamic hip system (dhs) lag 90mm lag screw, part number 280.900, lot number 7480815 became deformed during insertion.There was no reported generation of fragments.The surgeon was unable to place plate, part number 281.140 over the deformed lag screw.The deformed screw was successfully removed and replaced with another screw.There was no complaint alleged against the plate.The surgery was successfully completed with no patient injury, however, an operative delay of between 15 and 30 minutes was reported.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A review of the device history records was performed and no complaint related issues were found.Subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.Placeholder.

• Brand Name: DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: w. lindenmuth ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3576444
• MDR Text Key: 18300328
• Report Number: 3003506883-2014-00006
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.900
• Device Lot Number: 7480815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 81 YR