MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE,FIXATION,NAIL

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

Patient Problems Bone Fracture(s) (1870); Reaction (2414); No Code Available (3191)

Event Date 10/24/2006

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown dynamic hip screw (dhs)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: stenvall m., et al (2007) a multidisciplinary, multifactorial intervention program reduces postoperative falls and injuries after femoral neck fracture, osteoporos international volume 18, pages 167¿175 (sweden).This study aims to evaluate if a postoperative multidisciplinary, multifactorial intervention program could reduce inpatient falls and fall-related injuries in patients with femoral neck fractures.Between may 2000 and december 2002, patients with femoral neck fracture aged =70 years, consecutively admitted to the orthopedic department were included in the study.Patients were randomized, to postoperative care in a geriatric ward with a special intervention with 102 patients (74 females and ) with mean age of 82.3±6.6 program or to conventional care in an orthopedic ward with 97 patients (97 females) with mean age of 82.0±5.9.Depending on the degree of dislocation, the patients were treated with if using two hook-pins (swemac ortopedica, linköping, sweden) (n=38 intervention vs n=31 control) or with bipolar hemiarthroplasty (link, hamburg, germany) (n=57 vs 54).Basocervical fractures (n=7 vs 10) were operated on using a dynamic hip screw (dhs, stratec medical, oberdorf, switzerland).The following complications were reported as follows: one died before surgery in control group.6 participants died during hospitalization but were followed and analyzed until death in intervention group.7 participants died during hospitalization but were followed and analyzed until death in control group.Apart from the falls there were fewer other postoperative complications in the intervention group, such as fewer patients with postoperative delirium (p=0.003) and fewer delirious days (p=0.001), urinary tract infections (p=0.005), sleeping disturbances (p=0.009), nutritional problems (p=0.038), and decubitus ulcers.There were in total 3 minor or moderate injuries (mais 1-2) in the intervention group compared to 15 in the control group according to the ais.The serious injuries (mais 3) were new fractures of which four, two hip fractures, one rib fracture with pneumothorax, and one with multiple skull fractures, occurred in the control group and none in the intervention group.This report is for an unknown synthes dynamic hip screw.It captures the reported events of medical device site reaction and fractures.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10246422
• MDR Text Key: 200448237
• Report Number: 8030965-2020-04711
• 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: Physician
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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
• Date Manufacturer Received: 07/02/2020
• 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