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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 03/11/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. 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: hartmann f, hessmann mh, gercek e, rommens pm (2008). Elastic intramedullary nailing of midclavicular fractures. Acta chirurgica belgica. Volume 2008. Pages 428-432. ((b)(6)). The aim of the present study was the evaluation of the operative technique and the functional and re-integrative results after esin of displaced midclavicular fracture. Between 2003 and 2006, a total of 15 patients, with midclavicular fractures who underwent elastic stable intramedullary nailing (esin), were included in the study. There were 12 males and 3 females with an average of 36. 7 years (range, 15 to 65 years). Patients underwent fracture reduction and were implanted with an unknown synthes titanium elastic nail. Early physical therapy with a limitation of abduction of 90° is commenced for the first 3 to 4 weeks. Fracture healing, clinical outcome (visual analogue scale (vas) and clinical shoulder function per constant-murley score), and complications were assessed. Mean follow-up time was one year. Complications were reported as follows: a (b)(6) patient had complete acromioclavicular joint dislocation after reduction and elastic stable intramedullary nailing. Patient was revised with reconstruction of the acromioclavicular joint. Fracture healed after removal of titanium elastic nails (tens) at 16 weeks post injury. 4 patients had suffered from skin irritation and pain at the sternal end of the clavicle at 1 to 4 months post-op. The prominent medial end of the titanium elastic nail (ten) had to be shortened in 3 patients while it has to be removed early at 5 months post-op in 1 patient. 1 patient had a low activity level with constant-murley-score of 2 points. 1 year post-injury, patient had excellent function of the affected shoulder. Average vas-score of 1. 5+/-0. 5 points. Average constant-murley-score of 95. 3 +/- 3. 9 points. This report is for one (1) device- an unknown synthes titanium elastic nail. This is report 2 of 2 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 Key7924086
MDR Text Key122301904
Report Number8030965-2018-56884
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received09/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/01/2018 Patient Sequence Number: 1