MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø5 SELF-TAP L70 SST

Catalog Number 212.223

Device Problems Break (1069); Device Slipped (1584)

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: a patient with a right distal femur fracture was implanted with a plate and screws on (b)(6) 2013.Follow-up x-rays taken indicate two screws broken, the construct loosening and loss of reduction.The patient was returned to the operating room on (b)(6) 2014 for removal of hardware and unknown revision.This report is 8 of 11 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: device is used for treatment, not diagnosis.Additional codes: hrs, hwc.Reported lot number is not associated with the reported part number.Investigation could not be completed, no conclusion could be drawn as no device was returned.Part/lot combination unknown at synthes (b)(4).Therefore, dhr review is not possible.Placeholder.

Manufacturer Narrative

This medwatch is being rescinded.The complaint was reviewed on 02/04/2014 and event does not meet the definition of an mdr reportable event.The screw was not likely to result in patient harm or the need for additional medical or surgical intervention, the screw was received intact on 01/24/2014.

• Brand Name: LOCKSCR Ø5 SELF-TAP L70 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: jodi temple ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3573238
• MDR Text Key: 4141330
• Report Number: 8030965-2014-00100
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K000682
• 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
• Report Date: 12/17/2013

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: 212.223
• Device Lot Number: 8522797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70