MAUDE Adverse Event Report: SYNTHES USA; CERCLAGE, FIXATION

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Fixation of greater tochanter using an ao trochanteric reattachment device (ao trd) in arthroplasty for intertrochanteric femur fracture of elderly patients.Hip & pelvis, volume 25, issue 4, pp.274-279 (2013).Korea.This report is for unknown ao trochanteric reattachment device, unknown quantity, unknown lot.Patient code: (b)(4) for revision procedure to correct device failure.Device code: (b)(4) for device failure postoperatively 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.

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article: kim, w.Y., kim, y.Y., jeong, j.J., kang, d.J.(2013).Fixation of greater tochanter using an ao trochanteric reattachment device (ao trd) in arthroplasty for intertrochanteric femur fracture of elderly patients.Hip & pelvis, volume 25, issue 4, pp.274-279.Korea.The purpose of the study was to evaluate the efficacy of the trochanter reattachment device (trd) as a firm internal fixation method for bipolar hiarthroplasty in unstable intertrochanteric femur fractures in elderly patients.The study was conducted between september 2010 and april 2011 and included 19 patients (18 female, 1 male) with an average age of 80 years (range 68-91 years).The original study group included 45 patients; however, only 19 were able to be reached for follow-up.Each of the patients presented with complicated fractures and varying degrees of osteoporosis.The following complications were reported: one patient treated with a short trd presented with loosening of the trd plate requiring revision to achieve union a copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).This report is for unknown trochanter reattachment devices.

• Type of Device: CERCLAGE, FIXATION
• 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: 6503662
• MDR Text Key: 73221731
• Report Number: 2520274-2017-11270
• Device Sequence Number: 1
• Product Code: JDQ
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• 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: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention