MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; APPLIANCE, FIXATION, NAIL

Device Problem Break (1069)

Patient Problems Fall (1848); Necrosis (1971); Non-union Bone Fracture (2369)

Event Date 12/01/2005

Event Type  Injury  

Manufacturer Narrative

A total of 142 patients (69 male and 73 female) with a mean age of 69 years (range, 33-91 years).Exact date of event is unknown; december 01, 2005 is the date the literature article was published.This report is for an unknown synthes dynamic hip system construct/unknown lot.Part and lot number are unknown; udi number is unknown.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: wedin, r.And bauer, hcf.(2005), surgical treatment of skeletal metastatic lesions of the proximal femur: endoprosthesis or reconstruction nail?, the bone and joint journal, vol.87-b no.12, pages 1653-1657 (sweden) https://doi.Org/10.1302/0301-620x.87b12.16629.The aim of this retrospective study is to assess the reasons for reconstructive failures related to each method.Between 1996 and 2003, a total of 142 patients (69 male and 73 female) with a mean age of 69 years (range, 33-91 years) underwent surgical treatment of metastatic lesions of the proximal femur.The unreamed femoral nail (synthes stratec medical, oberdorf, switzerland was the locked intramedullary device used.The other reconstruction nail used was the proximal femoral nail (synthes stratec medical).The dynamic hip screw (dhs) synthes stratec medical) was the only sliding screw plate used.The mean follow-up was 1.6 years after the operation.The article did not specify which of the devices were being used to capture the following adverse events: 1 miscellaneous reason for re-operation, 1 was avascular necrosis of the femoral head 19 months after a subtrochanteric fracture had been treated successfully by dhs.Second case was caused by a fall 2 weeks after primary surgery leading to a breakage of a dhs.3 cases of nonunion occurred in 2 patients with reconstruction nails, and 1 with a dhs which broke at the site of the fracture, between 7 and 27 months after the primary surgery.This report is for an unknown synthes dynamic hip system construct.This is report 3 of 8 for (b)(4).

• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8654156
• MDR Text Key: 146506172
• Report Number: 8030965-2019-64678
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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: 05/02/2019
• 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