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Device Problem Bent (1059)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
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. Patient information is unknown the 510k: this report is for an unknown synthes titanium elastic nail/unknown lot. Part and lot number are unknown; udi number is unknown. 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. 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 is for patient 4a-nail bending after direct impact on the shoulder after collision with a pedestrian and was revised with a new and thicker ten. This report is for an unknown synthes titanium elastic nail. This is report 4 of 7 for (b)(4). A copy of the literature article is being submitted with this medwatch.
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
MDR Report Key7492078
MDR Text Key107528456
Report Number8030965-2018-53594
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/07/2018 Patient Sequence Number: 1