MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø6 SELF-TAP L60 F/DFN TAN TURQUO

Catalog Number 450.864S

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Erosion (1750)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports and event in (b)(6) as follows: it was reported on (b)(6), 2013, that a distal femoral nail was used for a supracondylar femur fracture case.On (b)(6), 2013, two weeks after the supracondylar femur fracture case operation, the surgeon confirmed radiographically the condyle part of the femur rotated and the nail end protruded from the bone.This report is 3 of 5 for complaint (b)(4).

Manufacturer Narrative

Device used for treatment not diagnosis.Pt age: 80s.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was performed and no complaint related issues were found.Placeholder.

• Brand Name: LOCKSCR Ø6 SELF-TAP L60 F/DFN TAN TURQUO
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: griselda webster ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3552818
• MDR Text Key: 19973624
• Report Number: 8030965-2013-05612
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: 450.864S
• Device Lot Number: 8482079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention