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

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Verheyden, akhil p.And josten, christoph (2003).Intramedullary fixation of intertrochanteric fractures with the proximal femoral nail (pfn).Orthop traumatol 2003: no.1: 20-37.This report is for unknown pfn set/unknown quantity/unknown lot.Other number: udi: unknown part number, udi is unavailable.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: verheyden, akhil p.And josten, christoph (2003).Intramedullary fixation of intertrochanteric fractures with the proximal femoral nail (pfn).Orthop traumatol 2003: no.1: 20-37.Between january 1, 1996 and march 31, 1999, the synthes proximal femoral nail (pfn) set was used in 231 patients (74.2% women, 25.8 men, average age 78.1 years) to treat inter-and subtrochanteric fractures allowing early weight bearing.This report is for an unknown pfn set and refers to the following: 1 deep infection which was accompanied by a complete implant loosening which required revision surgery.A copy of the literature article is being submitted with this medwatch.This is report 3 of 3 for (b)(4).

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5238569
• MDR Text Key: 31681251
• Report Number: 2520274-2015-17425
• 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: Other
• Type of Report: Initial
• Report Date: 11/08/2015

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?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2015
• Initial Date FDA Received: 11/20/2015
• 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