MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

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

Patient Problems Hematoma (1884); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.Muller, f et al (2016) peri-implant femoral fractures: the risk is more than three times higher within pfn compared with dhs.Injury, int.J.Care injured 47, pp: 2189¿2194.This report is for an unknown proximal femoral nailing system or and unknown dynamic hip screw (dhs).The article does not specify which system the patient was implanted with.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following journal article: muller, f et al (2016) peri-implant femoral fractures: the risk is more than three times higher within pfn compared with dhs.Injury, int.J.Care injured 47, pp: 2189¿2194.This study was performed as a retrospective study to provide scientific data concerning incidence and outcome of peri-implant femoral fractures (pif) following osteosynthesis of proximal femoral fractures (pff).This retrospective cohort study included only patients who had undergone surgery between january 1, 2006, and december 31, 2015.In terms of the type of osteosynthesis at the time of pif, 18 patients had a standard proximal femoral nail (pfn) (240 mm), 5 patients had a long pfn (380¿420 mm), and 3 patients had previously undergone dynamic hip screw (dhs).One revision was due to hematoma.This report is for an unknown proximal femoral nailing system or an unknown dynamic hip screw (dhs).This is report 2 of 2 for (b)(4).

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6475334
• MDR Text Key: 72203746
• Report Number: 2520274-2017-11234
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2017

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: 04/05/2017
• Initial Date FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention