MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR Ø5 SELF-TAP L80 SST

Catalog Number 02.231.280

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Device report received from synthes (b)(6) reports an event in (b)(6) as follows: patient was treated for a distal femur fracture in (b)(6) 2011.In (b)(6) 2013 the patient was operated on for pseudoarthrosis with a variable angle condylar plate.On (b)(6) 2013 it was noted the condylar plate had failed and it was removed.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa a review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.

Manufacturer Narrative

Device history record review was conducted and no complaint related issues were found.

Manufacturer Narrative

X-ray dates.

• Brand Name: VA LOCKSCR Ø5 SELF-TAP L80 SST
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3575215
• MDR Text Key: 15104013
• Report Number: 8030965-2014-00084
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• 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,Followup,Followup
• Report Date: 10/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.280
• Device Lot Number: 7596001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR