MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight not available for reporting.This report is for an unknown tfna helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant/explant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.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.Device was used for treatment, not diagnosis.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

This report is being filed after the review of the following journal article: akasaka y, tomoyama m (2017).Two cases of complications with the gamma intramedullary nail system for blade use.Orthopedic surgery volume 68.Number 5.Pages 441-444.((b)(6)) the purpose of the study is to report an experience with 2 cases in which rare complications developed from the use of the trochanteric fixation nail-advanced (tfna) system using the blade to perform osteosynthesis.Case 1 is an (b)(6) woman with a promixal femur fracture.She had an osteosynthesis performed with an unknown synthes tfna system using the blade.After insertion by driving the blade into the proximal bone fragment, the blade was pulled out from the femoral head with compression applied between the bone fragments.Due to the blade pull-out, surgical plan for osteosynthesis using the blade was replaced with a 10-mm long lag screw.Case 2 is a (b)(6) woman with a proximal femur fracture.She had an osteosynthesis performed with an unknown synthes tfna system using the blade.The reduction and implant placement were checked via fluoroscopy and plain x-ray imaging immediately after surgery, but no abnormalities were noticed.However, on the third day of surgery, it was established that the blade had passed through the front of the nail when it was inserted into the femoral head.Patient was revised with an artificial bone replacement.Figure 4.A.Of the article shows a mark of damage that can be seen on the front of the intramedullary nail.Figure 4.B.In the article shows a photograph of tfna device that when there is slack in the connection, the guide wire has the potential to pass through the outside of the intramedullary nail.This report is for an unknown synthes tfna helical blade.This is report 1 of 3 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7638336
• MDR Text Key: 112345793
• Report Number: 8030965-2018-54639
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: 06/01/2018
• 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
• Patient Age: 96 YR