MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - ELASTIC NAILS; NAIL, FIXATION, BONE

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

Patient Problems Irritation (1941); Discomfort (2330); Injury (2348); Hypoesthesia (2352); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown elastic nails/unknown lot.Part and lot numbers are unknown; udi 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.

Event Description

This report is being filed after the review of the following journal article: yuan h, et al.(2019), intramedullary nailing and minimally invasive percutaneous plate osteosynthesis in treatment of displaced clavicular mid-shaft fractures: a prospective study, z orthop unfall, page 1-7, (china).This study aimed to compare the differences between the minimally invasive plate osteosynthesis (mipo) and intramedullary nailing (imn) methods in the treatment of clavicular mid-shaft fractures.Between january 2012 to december 2017, 163 patients with displaced clavicular mid-shaft fractures were included in the study.These patients were randomly divided into the mipo group or the imn group.82 patients (52 females and 30 males, mean age of 40.9+/-13.2 years) received mipo and were implanted with a competitor¿s device.Meanwhile, 81 patients (54 females and 27 males, mean age of 40.7+/-14.9) received imn and were implanted with an unknown synthes elastic intramedullary nail.For both groups of patients, antibacterial therapy was conducted, and a sling was used immediately after surgery for 4 weeks.Both groups of patients were encouraged to do range of motion exercises for shoulder function.The mean follow-up duration was 9.3 +/- 2.6 (6 -14) months for all patients.Complications were reported as follows: 8 patients had nonunion.2 patients had a radial nerve injury.3 patients had skin numbness.4 patients had skin irritation or discomfort.2 patients had implant loosening.This report is for the unknown synthes elastic intramedullary nails.This report is for one (1) unk - elastic nails.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS
• Type of Device: NAIL, 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: 10588595
• MDR Text Key: 208774417
• Report Number: 8030965-2020-07465
• Device Sequence Number: 1
• Product Code: JDS
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: 09/02/2020
• 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