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 Unspecified Infection (1930); Injury (2348); Non-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 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) 2016 and (b)(6) 2018.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.

Event Description

This report is being filed after the review of the following journal article: an, l.Et al.(2020), clinical comparison of single-incision and dual-incision approaches for the treatment of distal tibial and fibular fractures: a randomized controlled trial, journal of orthopaedic surgery, vol.28(2), pages 1¿8 ((b)(6)) https://doi.Org/10.1177/2309499020930305.The purpose of this study was to clinically compare the single-incision and dual-incision approaches for the treatment of distal tibial and fibular fractures.Between june 2016 and june 2018, 93 patients presenting with distal tibial and fibular fractures underwent open reduction and internal fixation using either one-third tubular plate or distal fibular anatomical locking plate (ao/synthes, new jersey, usa).45 patients were treated using the single-incision approach (group 1) and 48 patients were treated using the dual-incision approach (group 2).The mean follow-up was 15 months (range 12¿19 months).The following complications were reported: group 1: 2 patients had skin slough, 2 patients had delayed union, 4 patients had nerve injury, 1 patient had an infection.Group 2: 5 patients had skin slough, 2 patients had superficial infection, 2 patients had nonuion which required surgical revisions and eventually healed after intervention, 5 patients had delayed union, 1 patient had a nerve injury.3 patients who had skin slough which required surgical revisions and eventually healed after intervention.This report is for an unknown synthes one-third tubular plate and distal fibular anatomical locking plate ((b)(6)).A copy of the literature article is being submitted with this medwatch.This is report 2 of 2 for (b)(4).

• 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10697066
• MDR Text Key: 216414224
• Report Number: 8030965-2020-08031
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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: 09/23/2020
• 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