MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Unspecified Infection (1930); Irritation (1941); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.The 510k: this report is for an unknown synthes titanium elastic nail end cap/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4) used to capture intra-operative inadequate advancement of ten into lateral fracture fragment.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: frima h., et al (2018) end cap versus no end cap in intramedullary nailing for displaced midshaft clavicle fractures: influence on implant-related irritation.European journal of trauma and emergency surgery volume 44.Pages 119-124.((b)(6)).The aim of this restrospective cohort study was to compare implant-related irritation rates of intramedullary (im) nailing with or without application of an end cap for displaced midshaft clavicle fractures (dmcf).All adult patients (=16 years) with a unilateral dmcf who were treated with an unknown synthes titanium elastic nail (ten) were included in this study.A total of 34 patients treated between 2007 and 2014 with an unknown synthes green titanium end cap were matched with 68 patients treated between january 2005 and december 2010 without an end cap.The standard clinical protocols dictate removal of the ten 3¿6 months postoperatively in all patients treated with im nailing for dmcf, or after adequate fracture healing in case of a delayed union.Patients were followed until the implant was removed.Primary outcome was patient-reported implant related irritation.Secondary outcome parameters were complications.According to table 2 and 3 of the article, complications were reported as follows: patients with end cap: patient 1a, who had follow-up at 12 weeks, had nail bending during abduction and was revised with a plate fixation.Patient 2a had an intra-operative lateral perforation.During follow-up at 1 week, patient experienced post-operative lateral migration with dislocation of end cap and was revised with a plate fixation.Patient 3a, who had follow-up at 12 weeks, had an unnoticed broken ten, which was discovered during outpatient visit.There was no union.Patient was revised to plate fixation with spongiosa transplantation.Patient 4a, who had follow-up at 10 weeks, had nail bending after direct impact on the shoulder after collision with a pedestrian and was revised with a new and thicker ten.There were 36 patients who experienced medial implant-related irritation, of which 24 were treated conservatively, 10 had minor revision, and 2 had implant removal.One patient who experienced lateral implant-related irritation was treated with minor revision.Patients with no end cap: patient 1b - intra-operative inadequate advancement of ten into lateral fracture fragment.There were 14 patients who experienced medial implant-related irritation, and 2 patients who experienced lateral implant-related irritation.All were treated conservatively.One patient had superficial infection.This report captures the following adverse events: medial implant-related irritation and lateral implant-related irritation superficial infection.This report is for an unknown synthes titanium elastic nail end cap.This is report 7 of 7 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7492196
• MDR Text Key: 107530319
• Report Number: 8030965-2018-53597
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• 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: 04/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention