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

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information: the study group included 41 men with a mean age of 70 years and 71 women with a mean age of 77 years.Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown cannulated screw /unknown lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: 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: stiasny j.Et al (2008), comparison analysis of the operative treatment results of the femoral neck fractures using side ¿ plate and compression screw and cannulated ao screws, ortopedia traumatologia rehabilitacja, volume 10, pages 350-361, (denmark).The aim of this study was to assess and compare the results of the surgical treatment of femoral neck fractures with the use unknown ao cannulated screws and a side-plate with a compression screw (unknown synthes dynamic hip system).Between 2004 and 2005, a total of 112 patients with femoral neck fractures treated surgically by internal fixation were assessed.The study group included 41 men with a mean age of 70 years and 71 women with a mean age of 77 years.Fracture fixation was done in 70 cases using 3 unknown ao cannulated screws, then a side-plate and compression screws in 22 cases, while fixation with a side-plate and compression screws with additional cannulated screws were done in 22 cases.The period of observation was from 2 to 36 months, 21.5 on average.The results of the treatment were assessed on the basis of physical examinations and radiographic evidence.Complications were reported as follows: roentgenometric assessment of the effectiveness of reduction in accordance with tavernier and lindenquist's criteria showed displacement of the fractured bony fragments below 2 mm in 102 cases.12 cases had a displacement of the bony fragments larger than 2 mm.54 patients had a minor shortening of the femoral neck not exceeding 50 percent of the head radius.30 patients had medium shortening.18 patients had a major shortening.26 patients had destabilization of the fixation.30 patients out of the 112 required revision surgery, including one patient needing revision surgery of the surgical wound for a vascular problem.For the ao screws sub-group, revision surgery was done due to the following: 7 patients had removal of fixation and were revised to total hip arthroplasty.5 patients had removal of fixation and were revised to hemiarthroplasty.6 patients had removal of connectors.2 patients had a replacement for stabilization.1 patient was revised due to infection.1 patient had a girdlestone joint left after the removal of the fixation.1 patient was revised due to bleeding.For the dhs sub-group, revision surgery was done due to the following: 1 patient had removal of fixation and was revised to total hip arthroplasty.1 patient had removal of fixation and was revised to hemiarthroplasty.1 patient had removal of connectors.1 patient had a girdlestone joint left after the removal of the fixation.For the dhs with additional cannulated ao screws sub-group, revision surgery was done due to the following: 1 patient had removal of fixation and was revised to total hip arthroplasty.1 patient had removal of fixation and was revised to hemiarthroplasty.This report is for an unknown cannulated screw.This is report 2 of 3 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: 8711896
• MDR Text Key: 148416717
• Report Number: 8030965-2019-65459
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 05/22/2019

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: 05/22/2019
• Initial Date FDA Received: 06/19/2019
• 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