MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Nerve Damage (1979); Loss of Range of Motion (2032); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown lcp plate and screw construct/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between (b)(6) 2013 and (b)(6) 2014.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: meluzinova p, et al (2015), plate osteosynthesis of distal ulna fractures with associated distal radius fractures treated by open reduction and internal fixation.Short-term functional and radiographic results, acta chirurgiae orthopaedicae et traumatologiae cechosl, volume 82, pages 369-376, (czech republic).The aim of the study was to describe the indication criteria and operative technique and to present the first conclusions of a prospective study dealing with an assessment of functional and radiographic findings in patients with concurrent fractures of the distal ulna and distal radius; the former was treated by osteosynthesis using a locking compression plate (lcp) distal ulna plate (de puy synthes, usa) and the latter by plate osteosynthesis.Between august 2013 and september 2014, 18 patients (3 men and 15 women; average age, 58 years; range, 25-74 years) with a fracture of the distal ulna and a concurrent distal radius fracture treated by plate osteosynthesis were included in the study.All patients were treated with an unknown synthes locking compression plate distal ulna plate for the distal ulnar fractures and an unknown synthes variable angle-locking compression plate for the distal radius fractures.The average follow-up was 9 months, with 13 patients being followed up for 6 months at least.Complications were reported as follows: 1 patient had an early repeated surgery due to incongruence of the articular surface of the radiocarpal joint as the result of an inadequately repositioned radial pillar.2 patients had an early repeated surgery due to the incorrect positioning of a screw in the radiocarpal joint.5 patients had post-operative irritation of the r.Dorsalis n.Ulnaris and soft tissues in the area of the distal part of the ulnar plate which made it necessary to remove the implant from 3 patients.1 patient developed symptoms of mild carpal tunnel syndrome, although the patient refused the recommended deliberation of the n.Medianus.This report is for the unknown synthes locking compression plate distal ulna plate, unknown synthes variable angle-locking compression plate and unknown synthes screws.This is report 1 of 3 for pc-(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.H6: code 3191 used to capture required surgical intervention.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 - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9621279
• MDR Text Key: 189993070
• Report Number: 8030965-2020-00555
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention