MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

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

Patient Problems Necrosis (1971); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patients are included in the study.This report is for an unk - screws: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant date is unknown.Dhr cannot be completed because lot number is unknown.(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: linde, f.Et al device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: linde, f.Et al (1986), avascular femoral head necrosis following fracture fixation, injury, vol.17, pages 159-163 (denmark).The present study was performed to ascertain whether there is any difference between the vascularity of the femoral head after inserting a sliding screw plate and after four ao cancellous bone screws.A total of 47 patients with a median age of 76 years range 34-92 years were treated with 4 6.5-mm ao cancellous bone screws.The following complications were reported as follows: 1 patient died before the operation but after allocation, 7 patients died before the scintigraphy assessment.3 patients had fair results on their garden alignment index while 5 patients had poor results.2 patients had reduced vascularity or probably avascular.3 patients were avascular.This report is for 4 6.5-mm ao cancellous bone screws.Article is being submitted with this medwatch.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: 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.

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9356402
• MDR Text Key: 185103661
• Report Number: 8030965-2019-70490
• Device Sequence Number: 1
• Product Code: HEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention