MAUDE Adverse Event Report: SYNTHES USA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Journal article received: distal medial closed wedge varus femur osteotomy stabilized with the tomofix plate fixator; ronald van heerwaarden, ate wymenga, denise freiling, phillipp lobenhoffer; operative techniques in orthopaedics; (2007) 17:12-21; reported: a new surgical technique for correction of valgus malalignment using an incomplete closing wedge osteotomy which is fixed with the tomofix plate fixator, locking head screws, cortex screws and locking head bolts (synthes devices).The indication of the technique, preoperative planning, step by step surgical technique and results were reported.It was noted that a total of 59 procedures were performed.The average wedge size was 7.3mm (range, 4-12); the mean patient age was 37.5 years.Fifty seven osteotomies healed uneventfully, two patients required secondary bone grafting and reosteosynthesis.There was one reported infection which healed after revision and one hematoma which required evacuation.The authors concluded that the tomofix plate fixator was a safe surgical technique for correction of valgus leg alignment.This report is for unknown locking head bolts.This is report 4 of 4 for complaint (b)(4).

Manufacturer Narrative

Distal medial closed wedge varus femur osteotomy stabilized with the tomofix plate fixator; ronald van heerwaarden, ate wymenga, denise freiling, phillipp lobenhoffer; operative techniques in orthopaedics; (2007) 17:12-21.This report is for unknown locking head bolts.(b)(4).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.(b)(4).Placeholder.

• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: elizabeth figlear ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3592733
• MDR Text Key: 4144493
• Report Number: 2520274-2014-00322
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2014
• Initial Date FDA Received: 01/27/2014
• 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