MAUDE Adverse Event Report: SYNTHES USA

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Device is used for treatment, not diagnosis.Journal article: tip apex distance, hip screw placement, and neck shaft angle as potential risk factors for cut-out failure of hip screws after surgical treatment of intertrochanteric fractures, hagen, a.Et al; international orthopaedics (sicot) (2012) 36:2347-2354.International orthopaedics (sicot) (2012) 36:2347-2354.Device is an unknown dhs/dcs, quantity 1.Cannot be determined without a part number.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.

Event Description

This report is being filed after the subsequent review of the following journal article:to describe the quality of osteosynthesis after intertrochanteric fractures evaluation of tip apex distance (tad) and position of the hip screw have been established.Furthermore, a slightly valgus fracture reduction has been suggested to reduce the risk of cut-out failure.However, uniform recommendations for optimal screw positioning and fracture reduction are still missing.The purpose of our study was to confirm potential risk factors for cut-out of hip screws of intertrochanteric fractures and to provide recommendations for practical clinical use.Two hundred thirty-five patients with intertrochanteric fractures after intra- and extramedullary stabilization were analyzed.Atad of more than 25mm was demonstrated to be the most important factor for cut-out in stable and unstable fractures.Fracture reduction with a valgus nsa of 5¿10 degree was associated with a trend towards a lower rate of screw cut-out while an anterior placement of the screw (parkers ratio index of greater than 40) significantly increased cut-out incidence.According to our results, the tad should not exceed 25 mm in stable (ao/ota a1) as well as unstable (ao/ota a2) fractures.An increased anterior hip screw placement should be avoided while fracture reduction with a slight valgus neck shaft seems favorable.A retrospective analysis of all patients with intertrochanteric fractures treated with a dhs (synthes, westchester, pa, usa) or a gamma 3 nail between january of 2007 and may of 2010 was performed at a level i trauma center.Most individuals were female (70.2 percent).Mean age was 80.8 to 11.0 years.The dhs was implanted in 80.0 percent (188 patients) while intramedullary stabilization was performed in 20 percent (47 patients).Following dhs osteosynthesis, cut-out was documented in six cases.This report is for an unknown dhs/dcs.This report is 1 of 1 for complaint (b)(4).

• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3638048
• MDR Text Key: 18563613
• Report Number: 2520274-2014-00736
• Device Sequence Number: 1
• Product Code: KTT
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1