MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW; APPLIANCE, FIXATION, NAIL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown dhs/dcs lag screw/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.(b)(4).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: gargan, m.F., gundle, r., and simpson, a.H.R.W (1994), how effective are osteotomies for unstable intertrochanteric fractures?, the journal of bone and joint surgery, vol.76(5), pages 789-792 (united kingdom).The aim of this study is to examine first whether osteotomies achieve their objective of a more stable configuration and secondly, by a prospective randomised trial, assesses the need for osteotomies in the treatment of unstable intertrochanteric fractures.A total of 100 patients with unstable intertrochanteric fractures of the femur was treated with ao dynamic hip screws (dhs).55 had an anatomical reduction and dhs fixation.The other 45 had an osteotomy followed by dhs fixation; 25 valgus and 20 medial displacement osteotomies were performed.The mean age of the patients was 82 years (60 to 100); there were 15 men and 85 women.The following complications were reported as follows: 9 patients died in hospital, four in the anatomical group and 5 in the valgus osteotomy group.2 other patients in the anatomical group died at home before union.12 of these patients had failure of the fixation before union.4 out of 49 in the anatomical group.8 out of 40 in the osteotomy group.9 cases the screw had penetrated the joint.2 cases screw had cut out of the neck, 1 case the plate had pulled off the femoral shaft.Other postoperative complications were similarly frequent in the 2 groups.There were 7 failures in the 34 patients who had an osteotomy before the introduction of the short-barrel device but only 1 failure in 11 treated after this.The use of a shorter barrel, when screws less than 85 mm are selected, increases the slide available and may reduce the failure rate.This report is for an unknown synthes ao dynamic hip screws (dhs).This report is for one (1) unknown dhs/dcs lag screw.This is report 1 of 3 for (b)(4).This report is linked to (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW
• 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: 10247380
• MDR Text Key: 203321007
• Report Number: 8030965-2020-04721
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 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?: Yes
• 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