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 Unspecified Infection (1930); Pain (1994); Hypoesthesia (2352); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes elastic stable intramedullary nail (esin)/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: fuglesang h., et al (2018), five-year follow-up results of a randomized controlled study comparing intramedullary nailing with plate fixation of completely displaced midshaft fractures of the clavicle in adults , jbjs open access, volume 3(4), pages 1-9 (norway) doi.Org/10.2106/jbjs.Oa.18.00009.This prospective randomized controlled study aims to determine whether the 12-month differences between closed and open esin were permanent and to compare the clinical outcomes and need for removal of the implant at a median follow-up of 66 months for patients who had been treated with pf or with closed or open esin.Between june 1, 2009, and september 30, 2012, a total of 353 clavicle fractures in patients between 16 and 60 years old were enrolled in the study.Of the 150 eligible patients, 123 were included in the study.Out of these patients, 114 completed questionnaires for follow-up.These patients were divided in to 2 groups: 60 patients (52 male and 8 female) with age at injury of 34.9 (16 to 59) were in plate fixation (pf) group treated with a 3.5-mm lcp (locking compression plate) and 54 patients (46 male and 8 female) with age at injury of 37.4 (17 to 58) in elastic stable intramedullary nailing (esin) group treated with a 2.0 to 3.5-mm titanium elastic nail, where 27 patients underwent open esin and 27 with closed esin.A median follow-up was done at 66 months after surgery (range, 49 to 89 months).The following complications were reported as follows: plate fixation (pf) group: 30 patients had incisional numbness.23 patients had pain when sleeping.22 patients had pain with a direct blow.11 patients had pain at rest.8 patients had painful clavicle.21 patients had pain with movement.1 patient had implant removal due to deep infection.8 patients had implant removal due to pain over implant.1 patients had implant removal due to cosmetic appearance.2 patients had secondary surgery due to deep infection.11 patients had implant removal due to skin-tenting.When patients who had a secondary operative procedure were excluded,48% of pf patients still had hypoesthesia at a median follow-up of 66 months after the primary operation.1 patient treated with pf died.Some patients had screw loosening from purchase in the bone.These patients received movement restrictions and their clavicles healed uneventfully.Elastic stable intramedullary nailing (esin) group: 12 patients had incisional numbness.13 patients had pain when sleeping.9 patients had pain with a direct blow.4 patients had pain at rest.4 patients had painful clavicle.12 patients had pain with movement.1 patient had implant removal due to superficial infection.9 patients had implant removal due to pain over implant.2 patients had implant removal due to cosmetic appearance.1 patient had secondary surgery due to nonunion.1 patient had secondary surgery for 1 nail placed outside lateral fragment was repositioned.28 patients had implant removal due to skin tenting.When patients who had a secondary operative procedure were excluded,33% of esin patients still had hypoesthesia at a median follow-up of 66 months after the primary operation.10 patients had secondary surgery for shortening of nail due to skin-tenting.1 patient secondary surgery due implant failure.1 patient had a nail bent, the diameter of 2.0 mm was probably insufficient for it´s use.This is report 3 of 5 for (b)(4).This report is for an unknown synthes elastic stable intramedullary nail (esin).

• 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: 8870041
• MDR Text Key: 153556242
• Report Number: 8030965-2019-66941
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2019
• 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